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									tsWidth3\clwWidth6300\clshdrawnil \cellx6230\clvertalt\clbrdrt\brdrnone
\clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth2770\clshdrawnil \cellx9000\row
\ltrrow}\trowd \irow8\irowband8\ltrrow
\ts11\trqc\trgaph70\trleft-70\trkeep\trbrdrt\brdrdb\brdrw10
\trbrdrl\brdrdb\brdrw10 \trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10
\trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10
\cltxlrtb\clftsWidth3\clwWidth6300\clshdrawnil \cellx6230
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone
\clbrdrr\brdrdb\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2770\clshdrawnil
\cellx9000\pard \ltrpar
\ql
\li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adj
ustright\rin0\lin0 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
Is}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420 the}{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
quality system certified ?\cell }\pard \ltrpar\ql
\li0\ri0\sb60\sa60\widctlpar\intbl
\tx290\tx1550\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0
{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\tab }{\field\flddirty\fldpriv{\*\fldinst {\rtlch\fcs1 \af1\afs18
\ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
FORMCHECKBOX }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid526294 {\*\datafield
65000000140000000c5a619a6b7274e1766163ed3200000000000000000000000000}{\*\
formfield{\fftype1\ffres25\fftypetxt0\ffhps20{\*\ffname
Za\'9akrt\'e1vac\'ed2}\ffdefres0}}}}{\fldrslt }}\sectd \ltrsect
\psz9\linex0\headery567\footery454\colsx708\endnhere\titlepg\pgbrdropt32\
sectlinegrid360\sectdefaultcl\sectrsid538236\sftnbj {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
Yes\tab }
{\field\flddirty\fldpriv{\*\fldinst {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
FORMCHECKBOX }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid526294
{\*\datafield
65000000140000000c5a619a6b7274e1766163ed3200000000000000000000000000}{\*\
formfield{\fftype1\ffres25\fftypetxt0\ffhps20{\*\ffname
Za\'9akrt\'e1vac\'ed2}\ffdefres0}}}}{\fldrslt }}\sectd \ltrsect
\psz9\linex0\headery567\footery454\colsx708\endnhere\titlepg\pgbrdropt32\
sectlinegrid360\sectdefaultcl\sectrsid538236\sftnbj {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
No\cell
}\pard \ltrpar\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0 {\rtlch\fcs1 \ab\af0\afs18 \ltrch\fcs0
\b\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\trowd \irow8\irowband8\ltrrow
\ts11\trqc\trgaph70\trleft-70\trkeep\trbrdrt\brdrdb\brdrw10
\trbrdrl\brdrdb\brdrw10 \trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10
\trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10
\cltxlrtb\clftsWidth3\clwWidth6300\clshdrawnil \cellx6230
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone
\clbrdrr\brdrdb\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2770\clshdrawnil
\cellx9000\row \ltrrow}\pard \ltrpar
\ql
\li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adj
ustright\rin0\lin0 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
Are the test reports of the accredited testing laboratories
available?\cell }\pard \ltrpar\ql
\li0\ri0\sb60\sa60\widctlpar\intbl\tx290\tx1550\wrapdefault\aspalpha\aspn
um\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\tab }{\field\flddirty\fldpriv{\*\fldinst {\rtlch\fcs1 \af1\afs18
\ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
FORMCHECKBOX }{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid526294 {\*\datafield
65000000140000000c5a619a6b7274e1766163ed3200000000000000000000000000}{\*\
formfield{\fftype1\ffres25\fftypetxt0\ffhps20{\*\ffname
Za\'9akrt\'e1vac\'ed2}\ffdefres0}}}
}{\fldrslt }}\sectd
\ltrsect\psz9\linex0\headery567\footery454\colsx708\endnhere\titlepg\pgbr
dropt32\sectlinegrid360\sectdefaultcl\sectrsid538236\sftnbj {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
Yes\tab }{\field\flddirty\fldpriv{\*\fldinst {\rtlch\fcs1 \af1\afs18
\ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
FORMCHECKBOX }{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid526294 {\*\datafield
65000000140000000c5a619a6b7274e1766163ed3200000000000000000000000000}{\*\
formfield{\fftype1\ffres25\fftypetxt0\ffhps20{\*\ffname
Za\'9akrt\'e1vac\'ed2}\ffdefres0}}}
}{\fldrslt }}\sectd
\ltrsect\psz9\linex0\headery567\footery454\colsx708\endnhere\titlepg\pgbr
dropt32\sectlinegrid360\sectdefaultcl\sectrsid538236\sftnbj {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
No\cell }\pard \ltrpar\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0 {\rtlch\fcs1 \ab\af0\afs18 \ltrch\fcs0
\b\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\trowd \irow9\irowband9\ltrrow\ts11\trqc\trgaph70\trleft-
70\trkeep\trbrdrt\brdrdb\brdrw10 \trbrdrl\brdrdb\brdrw10
\trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10 \trbrdrh
\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10
\cltxlrtb\clftsWidth3\clwWidth6300\clshdrawnil
\cellx6230\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10
\clbrdrb\brdrnone \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth2770\clshdrawnil \cellx9000\row \ltrrow
}\trowd \irow10\irowband10\ltrrow\ts11\trqc\trgaph70\trleft-
70\trkeep\trbrdrt\brdrdb\brdrw10 \trbrdrl\brdrdb\brdrw10
\trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10 \trbrdrh\brdrs\brdrw10
\trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrnone
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10
\cltxlrtb\clftsWidth3\clwWidth6300\clshdrawnil \cellx6230
\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10
\clbrdrr\brdrdb\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2770\clshdrawnil
\cellx9000\pard \ltrpar\ql \li0\ri0\sb60\sa60\widctlpar\intbl
\tx470\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0
{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420 If yes, specify
}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid12390482 the test reports
}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420 in
list:}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\par }\pard \ltrpar\ql
\li0\ri0\sb60\sa60\widctlpar\intbl\tx3530\wrapdefault\aspalpha\aspnum\faa
uto\adjustright\rin0\lin0 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420
\par }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\par \cell
\par }\pard \ltrpar\ql
\li0\ri0\sb60\sa60\widctlpar\intbl\tx290\tx1550\wrapdefault\aspalpha\aspn
um\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\cell }\pard \ltrpar
\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0 {\rtlch\fcs1 \ab\af0\afs18 \ltrch\fcs0
\b\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\trowd \irow10\irowband10\ltrrow
\ts11\trqc\trgaph70\trleft-70\trkeep\trbrdrt\brdrdb\brdrw10
\trbrdrl\brdrdb\brdrw10 \trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10
\trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrnone
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10
\cltxlrtb\clftsWidth3\clwWidth6300\clshdrawnil \cellx6230
\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10
\clbrdrr\brdrdb\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2770\clshdrawnil
\cellx9000\row \ltrrow}\trowd
\irow11\irowband11\ltrrow\ts11\trqc\trgaph70\trleft-70\trkeep\trbrdrt
\brdrdb\brdrw10 \trbrdrl\brdrdb\brdrw10 \trbrdrb\brdrdb\brdrw10
\trbrdrr\brdrdb\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt
\brdrs\brdrw10 \clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrs\brdrw10
\clbrdrr\brdrdb\brdrw15 \cltxlrtb\clftsWidth3\clwWidth9070\clshdrawnil
\cellx9000\pard \ltrpar\ql \li0\ri0\sb60\sa60\widctlpar\intbl
\tx290\tx1550\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0
{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
List of documents concerning to your quality system (}{\rtlch\fcs1
\ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
certificates, audit reports, \'85}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023 )
\par
\par
\par
\par \cell }\pard \ltrpar\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0 {\rtlch\fcs1 \ab\af0\afs18 \ltrch\fcs0
\b\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\trowd \irow11\irowband11\ltrrow
\ts11\trqc\trgaph70\trleft-70\trkeep\trbrdrt\brdrdb\brdrw10
\trbrdrl\brdrdb\brdrw10 \trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10
\trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth9070\clshdrawnil
\cellx9000\row \ltrrow}\trowd \irow12\irowband12\lastrow
\ltrrow\ts11\trqc\trgaph70\trrh880\trleft-
70\trkeep\trbrdrt\brdrdb\brdrw10 \trbrdrl\brdrdb\brdrw10
\trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10 \trbrdrh\brdrs\brdrw10
\trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrdb\brdrw10 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth9070\clshdrawnil
\cellx9000\pard \ltrpar\ql
\li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adj
ustright\rin0\lin0 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
Another documents (}{
\rtlch\fcs1 \ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
information, \'85}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
):
\par }\pard \ltrpar\ql
\li0\ri0\sb60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustri
ght\rin0\lin0 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\par }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420
\par
\par }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid14491951
\par
\par }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid355891\charrsid11546023
\par }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\cell }\pard \ltrpar\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\trowd \irow12\irowband12\lastrow
\ltrrow\ts11\trqc\trgaph70\trrh880\trleft-
70\trkeep\trbrdrt\brdrdb\brdrw10 \trbrdrl\brdrdb\brdrw10
\trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10
\trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrdb\brdrw10 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth9070\clshdrawnil \cellx9000\row }\pard
\ltrpar\ql
\li0\ri0\widctlpar\tx5400\wrapdefault\aspalpha\aspnum\faauto\adjustright\
rin0\lin0\itap0 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420
\par }\pard \ltrpar\qc
\li0\ri0\sa240\widctlpar\tx5400\wrapdefault\aspalpha\aspnum\faauto\adjust
right\rin0\lin0\itap0\pararsid14491951 {\rtlch\fcs1 \af1\afs18
\ltrch\fcs0 \f1\fs18\lang2057\langfe1029\langnp2057\insrsid14491951 \page
}{\rtlch\fcs1 \af1\afs28
\ltrch\fcs0
\f1\fs28\cf2\lang2057\langfe1029\langnp2057\insrsid14491951\charrsid47942
9 Guidance for proper filling of particular fields in the application
form
\par }\pard \ltrpar\qj
\li0\ri0\sb120\widctlpar\tx5400\wrapdefault\aspalpha\aspnum\faauto\adjust
right\rin0\lin0\itap0\pararsid14491951 {\rtlch\fcs1 \af1\afs22
\ltrch\fcs0
\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951\charrsid2912788
Data }{
\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951 in the first
table under legend APPLICANT serve to
 identification of manufacturer and are on the certificate inscribed.
There is strictly necessary to specify the exact name and address of the
manufacturer (data shall be identical with those printed on the label of
medical devices in question) and VAT nu
mber or other Identification number. Information about bank requisites
(}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
\i\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951 bank
name}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
\i\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951\charrsid4213608
, account number, IBAN and}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
\i\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951
/or}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
\i\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951\charrsid4213608
SWIFT code}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951
) is important for the sake of contract proposal and information about
contact persons with e-mail, phone and fax number as well.
\par The second table must be duly complete with product trade names,
which will be on }{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
\f1\fs22\lang2057\langfe1029\langnp2057\insrsid6629439 relevant
certificates uploaded. }{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951 Detailed
specification of devices concerning type and/or model can be filled
in}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951\charrsid3680600
 referring to }{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951 appropriate parts
of page 2.
\par The manufacturer shall identify if the devices contain }{\rtlch\fcs1
\af1\afs22 \ltrch\fcs0
\f1\fs22\lang2057\langfe1029\langnp2057\insrsid6629439 radioactive
sources}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951 .
\par Information in the further section shall be given }{\rtlch\fcs1
\af1\afs22 \ltrch\fcs0
\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951\charrsid3680600
in the event of}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951 the
manufacturer's name and address is different from applicant\rquote s one
or in the case that the company is an integral part of some larger
organization.
\par Conformity assessment procedure shall be specified in the third
table considering the classification mentioned above.
\par If you are }{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951\charrsid8211623
not exactly}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
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}{\rtlch\fcs1
\af1\afs22 \ltrch\fcs0
\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951\charrsid8211623
selection}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951
 of feasible procedure and are interested in guidance on that, tick
\'93yes\'94 in the relevant field. (}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
\i\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951\charrsid1546913
7 Additional fee }{\rtlch\fcs1
\af1\afs22 \ltrch\fcs0
\i\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951 for the
guidance }{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
\i\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951\charrsid1546913
7 amounting 100,- \'80}{\rtlch\fcs1 \af1\afs22
\ltrch\fcs0 \i\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951
}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
\i\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951\charrsid1546913
7 can be invoiced in that case}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951 ).
\par In the last line of this table there is necessary to provide the
Notified Body with information which language version of certificates
which will be required.
\par The further three declarations express the applicant\rquote s
agreement with the common conditions of the conformity assessment
procedure applied by ITC. Client\rquote s signature and date of
application are strongly necessary.
\par On the second page, the name of devices shall be inscribed in the
first line together with product, its main parts and critical material
description (especially when a medicine, animal tissues or blood
derivatives are used in the medical device).
\par Within second line important parts of technical documentation with
decisive impact on classification of the devices in relation to intended
use and critical material shall be listed.
\par In the further line, the intended use of devices shall be described
in detail.
\par Next part of the table shall provide an a
ssessor with information whether these devices were placed on the market,
when and in which countries in order that the relevant information and
experiences of end-users from post-production phase of the devices should
be }{\rtlch\fcs1 \af1\afs22
\ltrch\fcs0
\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951\charrsid7565562
corroborate}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951 d.
\par Additional enquiries concern a manufacturer's quality system and its
possible certification. This information is important and helpful to
auditors with arrangement of an audit and quality system documents
review.
\par In the following line information shall render if the devices and
materials with decisive action on parameters of the devices were tested
at approved testing houses.
\par Next line shall contain not only certificates but also list of
documents relative to manufacturer's quality system, especially when the
system hasn't been certified yet (standard operational procedures, work
instructions etc.).
\par The last part of the table involves information concerning main
subcontractors, theirs quality system, }{\rtlch\fcs1 \af1\afs22
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con}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
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tractu}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
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al}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951 liaison
etc.}{\rtlch\fcs1 \af1\afs22 \ltrch\fcs0
\f1\fs22\lang2057\langfe1029\langnp2057\insrsid14491951\charrsid7686045
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\lsdpriority32 \lsdlocked0 Intense Reference;\lsdqformat1 \lsdpriority33
\lsdlocked0 Book Title;\lsdsemihidden1 \lsdunhideused1 \lsdpriority37
\lsdlocked0 Bibliography;
\lsdsemihidden1 \lsdunhideused1 \lsdqformat1 \lsdpriority39 \lsdlocked0
TOC Heading;}}{\*\datastore
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\sectd
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INSTITUTE FOR TESTING AND CERTIFICATION, }{\rtlch\fcs1 \ab\af1
\ltrch\fcs0
\b\f1\cf2\lang2057\langfe1029\langnp2057\insrsid16597048\charrsid11546023
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}\pard\plain \ltrpar
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\f1\fs12\lang2057\langfe1029\langnp2057\insrsid16597048\charrsid11546023
Institut pro testov\'e1n\'ed a certifikaci, a.s.\tab
Banking with: Komer\'e8n\'ed banka Zl\'edn\tab Company Id. No.:
47910381\tab Phone:\tab (+420) 577 601 328, 577 601 621
\par }\pard \ltrpar\s17\ql \li0\ri-
82\widctlpar\tx1305\tx2340\tx4680\tx6840\tx7258\tqr\tx9072\wrapdefault\as
palpha\aspnum\faauto\adjustright\rin-82\lin0\itap0\pararsid13390101
{\rtlch\fcs1 \af1\afs12 \ltrch\fcs0
\f1\fs12\lang2057\langfe1029\langnp2057\insrsid16597048\charrsid11546023
Tr. Tomase Bati 299\tab }{\rtlch\fcs1 \af1\afs12 \ltrch\fcs0
\f1\fs12\lang2057\langfe1029\langnp2057\insrsid16597048 \tab
}{\rtlch\fcs1 \af1\afs12 \ltrch\fcs0
\f1\fs12\lang2057\langfe1029\langnp2057\insrsid16597048\charrsid11546023
Acc. No.: 86-2113330267/0100\tab Tax & VAT Id. No.: CZ47910381\tab Fax:
\tab (+420) 577 104 855, 577 601 653
\par }\pard \ltrpar\s17\ql \li0\ri-
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aspnum\faauto\adjustright\rin-82\lin0\itap0\pararsid11546023 {\rtlch\fcs1
\af1\afs12 \ltrch\fcs0
\f1\fs12\lang2057\langfe1029\langnp2057\insrsid16597048\charrsid11546023
CZ-764 21 Zl\'edn\tab IBAN: CZ8801000000862113330267\tab Registered at:
KS Brno, CZ\tab e-mail: \tab marketing@itczlin.cz
\par Czech Republic\tab SWIFT Code: KOMBCZPP\tab Registration file No.:
Rg. B/1002\tab Internet pages: http:/www.itczlin.cz}{\rtlch\fcs1
\af1\afs12 \ltrch\fcs0
\f1\fs12\lang2057\langfe1029\langnp2057\insrsid16597048
\par }{\rtlch\fcs1 \af1\afs12 \ltrch\fcs0
\f1\fs12\lang2057\langfe1029\langnp2057\insrsid538236
\par appl_AIMD_2009_07_21}{\rtlch\fcs1 \af1\afs12 \ltrch\fcs0
\f1\fs12\lang2057\langfe1029\langnp2057\insrsid538236\charrsid11546023
\par }}{\*\pnseclvl1\pnucrm\pnstart1\pnindent720\pnhang {\pntxta
.}}{\*\pnseclvl2\pnucltr\pnstart1\pnindent720\pnhang {\pntxta
.}}{\*\pnseclvl3\pndec\pnstart1\pnindent720\pnhang {\pntxta
.}}{\*\pnseclvl4\pnlcltr\pnstart1\pnindent720\pnhang {\pntxta )}}
{\*\pnseclvl5\pndec\pnstart1\pnindent720\pnhang {\pntxtb (}{\pntxta
)}}{\*\pnseclvl6\pnlcltr\pnstart1\pnindent720\pnhang {\pntxtb (}{\pntxta
)}}{\*\pnseclvl7\pnlcrm\pnstart1\pnindent720\pnhang {\pntxtb (}{\pntxta
)}}{\*\pnseclvl8
\pnlcltr\pnstart1\pnindent720\pnhang {\pntxtb (}{\pntxta
)}}{\*\pnseclvl9\pnlcrm\pnstart1\pnindent720\pnhang {\pntxtb (}{\pntxta
)}}\pard\plain \ltrpar\qc
\li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\li
n0\itap0 \rtlch\fcs1
\af0\afs24\alang1025 \ltrch\fcs0
\fs24\lang1029\langfe1029\cgrid\langnp1029\langfenp1029 {\rtlch\fcs1
\ab\af1\afs8 \ltrch\fcs0
\b\f1\fs8\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\par }\pard \ltrpar\qc
\li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\li
n0\itap0\pararsid7088162 {\rtlch\fcs1 \ab\af1\afs28 \ltrch\fcs0
\b\f1\fs28\lang2057\langfe1029\langnp2057\insrsid11546023 AP}{\rtlch\fcs1
\ab\af1\afs28 \ltrch\fcs0
\b\f1\fs28\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
PLICATION FOR CONFORMITY ASSESSMENT
\par }\pard\plain \ltrpar\s2\qc
\li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\outlinelevel1\adjus
tright\rin0\lin0\itap0\pararsid7088162 \rtlch\fcs1
\ab\af0\afs28\alang1025 \ltrch\fcs0
\b\caps\fs28\lang1029\langfe1029\cgrid\langnp1029\langfenp1029 {
\rtlch\fcs1 \af1 \ltrch\fcs0
\caps0\f1\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
OF }{\rtlch\fcs1 \af1 \ltrch\fcs0
\caps0\f1\lang2057\langfe1029\langnp2057\insrsid9330957 ACTIVE
IMPLANTABLE}{\rtlch\fcs1 \af1 \ltrch\fcs0
\caps0\f1\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
MEDICAL DEVICES}{\rtlch\fcs1 \af1 \ltrch\fcs0
\caps0\f1\lang2057\langfe1029\langnp2057\insrsid1992602 (}{\rtlch\fcs1
\af1 \ltrch\fcs0
\caps0\f1\lang2057\langfe1029\langnp2057\insrsid16725290 AIM}{\rtlch\fcs1
\af1 \ltrch\fcs0 \caps0\f1\lang2057\langfe1029\langnp2057\insrsid1992602
D}{\rtlch\fcs1 \af1 \ltrch\fcs0
\caps0\f1\lang2057\langfe1029\langnp2057\insrsid16207100 )}{\rtlch\fcs1
\af1 \ltrch\fcs0
\caps0\f1\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\par }\pard\plain \ltrpar\qc
\li0\ri0\sb60\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\ri
n0\lin0\itap0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0
\fs24\lang1029\langfe1029\cgrid\langnp1029\langfenp1029 {\rtlch\fcs1
\ab\af1\afs20 \ltrch\fcs0
\b\f1\fs20\lang2057\langfe1029\langnp2057\insrsid16207100 a}{\rtlch\fcs1
\ab\af1\afs20 \ltrch\fcs0
\b\f1\fs20\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
ccord}{\rtlch\fcs1 \ab\af1\afs20 \ltrch\fcs0
\b\f1\fs20\lang2057\langfe1029\langnp2057\insrsid16207100
ing}{\rtlch\fcs1 \ab\af1\afs20 \ltrch\fcs0
\b\f1\fs20\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
}{\rtlch\fcs1 \ab\af1\afs20 \ltrch\fcs0
\b\f1\fs20\lang2057\langfe1029\langnp2057\insrsid16207100 to
the}{\rtlch\fcs1 \ab\af1\afs18 \ltrch\fcs0
\b\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
Article No. 9 }{\rtlch\fcs1 \ab\af1\afs18 \ltrch\fcs0
\b\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16207100 of the
}{\rtlch\fcs1 \ab\af1\afs18 \ltrch\fcs0
\b\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
Directive 9}{\rtlch\fcs1 \ab\af1\afs18 \ltrch\fcs0
\b\f1\fs18\lang2057\langfe1029\langnp2057\insrsid9330957
0/385}{\rtlch\fcs1 \ab\af1\afs18 \ltrch\fcs0
\b\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
/E}{\rtlch\fcs1 \ab\af1\afs18 \ltrch\fcs0
\b\f1\fs18\lang2057\langfe1029\langnp2057\insrsid9330957 E}{\rtlch\fcs1
\ab\af1\afs18 \ltrch\fcs0
\b\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
C}{\rtlch\fcs1 \ab\af1\afs18 \ltrch\fcs0
\b\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595 as
amended}{\rtlch\fcs1 \ab\af1\afs18 \ltrch\fcs0
\b\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\par }\pard\plain \ltrpar\s15\qc
\li0\ri0\widctlpar\tx2880\tx5580\tx7740\wrapdefault\aspalpha\aspnum\faaut
o\adjustright\rin0\lin0\itap0\pararsid16207100 \rtlch\fcs1
\af0\afs22\alang1025 \ltrch\fcs0
\fs22\lang1029\langfe1029\cgrid\langnp1029\langfenp1029 {
\rtlch\fcs1 \af1\afs12 \ltrch\fcs0
\f1\fs12\lang2057\langfe1029\langnp2057\insrsid16207100\charrsid10230902
\par }\pard\plain \ltrpar\ql
\li0\ri0\sb40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustri
ght\rin0\lin0\itap2\pararsid7872705 \rtlch\fcs1 \af0\afs24\alang1025
\ltrch\fcs0 \fs24\lang1029\langfe1029\cgrid\langnp1029\langfenp1029
{\rtlch\fcs1
\ab\af1\afs22 \ltrch\fcs0
\b\f1\fs22\lang2057\langfe1029\langnp2057\insrsid4013625\charrsid2714307
No.}{\rtlch\fcs1 \ab\af1\afs22 \ltrch\fcs0
\b\f1\fs22\lang2057\langfe1029\langnp2057\insrsid4013625 :}{\rtlch\fcs1
\ab\af1\afs22 \ltrch\fcs0
\b\f1\fs22\lang2057\langfe1029\langnp2057\insrsid4013625\charrsid2714307
\nestcell{\nonesttables
\par }}\pard \ltrpar\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0\itap2 {\rtlch\fcs1 \ab\af1\afs22 \ltrch\fcs0
\b\f1\fs22\lang2057\langfe1029\langnp2057\insrsid4013625\charrsid2714307
{\*\nesttableprops
\trowd \irow0\irowband0\lastrow
\ltrrow\ts11\trqc\trgaph70\trrh284\trleft0\trbrdrt\brdrdb\brdrw15
\trbrdrl\brdrdb\brdrw15 \trbrdrb\brdrdb\brdrw15 \trbrdrr\brdrdb\brdrw15
\trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrnone \clbrdrl\brdrnone
\clbrdrb\brdrnone \clbrdrr\brdrnone
\cltxlrtb\clftsWidth3\clwWidth630\clshdrawnil \cellx630
\nestrow}{\nonesttables
\par }\ltrrow}\trowd \irow0\irowband0\lastrow
\ltrrow\ts11\trqc\trgaph70\trrh284\trleft-70\trbrdrt\brdrdb\brdrw15
\trbrdrl\brdrdb\brdrw15 \trbrdrb\brdrdb\brdrw15 \trbrdrr\brdrdb\brdrw15
\trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrnone \clbrdrl\brdrnone
\clbrdrb\brdrnone \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth533\clshdrawnil \cellx463\clvertalt
\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrdb\brdrw15
\clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil
\cellx803\clvertalt\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrs\brdrw15
\clbrdrb\brdrdb\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil
\cellx1143\clvertalt\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrs\brdrw15
\clbrdrb\brdrdb\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil
\cellx1483\clvertalt\clbrdrt\brdrdb\brdrw15
\clbrdrl\brdrs\brdrw15 \clbrdrb\brdrdb\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil
\cellx1823\clvertalt\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrs\brdrw15
\clbrdrb\brdrdb\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil
\cellx2163\clvertalt\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrs\brdrw15
\clbrdrb\brdrdb\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil
\cellx2503\clvertalt\clbrdrt\brdrdb\brdrw15
\clbrdrl\brdrs\brdrw15 \clbrdrb\brdrdb\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil
\cellx2843\clvertalt\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrs\brdrw15
\clbrdrb\brdrdb\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil
\cellx3183\clvertalt\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrs\brdrw15
\clbrdrb\brdrdb\brdrw15 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil \cellx3523\pard \ltrpar
\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0\pararsid7872705 {\rtlch\fcs1 \ab\af1\afs22 \ltrch\fcs0
\b\f1\fs22\lang2057\langfe1029\langnp2057\insrsid16207100\charrsid1023090
2 \cell }{\rtlch\fcs1 \ab\af1\afs20
\ltrch\fcs0
\b\caps\f1\fs20\lang2057\langfe1029\langnp2057\insrsid16207100\charrsid10
230902 \cell \cell \cell \cell \cell \cell \cell \cell \cell }\pard
\ltrpar\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0 {
\rtlch\fcs1 \ab\af1\afs20 \ltrch\fcs0
\b\caps\f1\fs20\lang2057\langfe1029\langnp2057\insrsid16207100\charrsid10
230902 \trowd \irow0\irowband0\lastrow
\ltrrow\ts11\trqc\trgaph70\trrh284\trleft-70\trbrdrt\brdrdb\brdrw15
\trbrdrl\brdrdb\brdrw15 \trbrdrb
\brdrdb\brdrw15 \trbrdrr\brdrdb\brdrw15 \trbrdrh\brdrs\brdrw15
\trbrdrv\brdrs\brdrw15
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrnone \clbrdrl\brdrnone
\clbrdrb\brdrnone
\clbrdrr\brdrdb\brdrw15 \cltxlrtb\clftsWidth3\clwWidth533\clshdrawnil
\cellx463\clvertalt\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrdb\brdrw15
\clbrdrb\brdrdb\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil \cellx803\clvertalt
\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrs\brdrw15 \clbrdrb\brdrdb\brdrw15
\clbrdrr\brdrs\brdrw15 \cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil
\cellx1143\clvertalt\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrs\brdrw15
\clbrdrb\brdrdb\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil
\cellx1483\clvertalt\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrs\brdrw15
\clbrdrb\brdrdb\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil
\cellx1823\clvertalt\clbrdrt\brdrdb\brdrw15
\clbrdrl\brdrs\brdrw15 \clbrdrb\brdrdb\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil
\cellx2163\clvertalt\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrs\brdrw15
\clbrdrb\brdrdb\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil
\cellx2503\clvertalt\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrs\brdrw15
\clbrdrb\brdrdb\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil
\cellx2843\clvertalt\clbrdrt\brdrdb\brdrw15
\clbrdrl\brdrs\brdrw15 \clbrdrb\brdrdb\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil
\cellx3183\clvertalt\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrs\brdrw15
\clbrdrb\brdrdb\brdrw15 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil \cellx3523\row }\pard\plain
\ltrpar\s15\qj
\li0\ri0\widctlpar\tx3420\tx5580\tx7740\wrapdefault\aspalpha\aspnum\faaut
o\adjustright\rin0\lin0\itap0\pararsid16207100 \rtlch\fcs1
\af0\afs22\alang1025 \ltrch\fcs0
\fs22\lang1029\langfe1029\cgrid\langnp1029\langfenp1029 {\rtlch\fcs1
\af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid16207100\charrsid10230902
\tab ITC\rquote s Registry Number (do not fill in)
\par }\pard\plain \ltrpar\ql
\li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\li
n0\itap0\pararsid16207100 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0
\fs24\lang1029\langfe1029\cgrid\langnp1029\langfenp1029 {\rtlch\fcs1
\ab\af1\afs22
\ltrch\fcs0
\b\caps\f1\fs22\lang2057\langfe1029\langnp2057\insrsid16207100\charrsid10
230902 APPLICANT:
\par \ltrrow}\trowd
\irow0\irowband0\ltrrow\ts11\trgaph70\trrh284\trleft0\trkeep\trbrdrt\brdr
s\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15
\trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15
\trftsWidth3\trwWidth9072\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\t
rpaddfl3\trpaddfr3\tblind70\tblindtype3 \clvertalc\clbrdrt\brdrdb\brdrw15
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth4680\clshdrawnil
\cellx4666\clvertalc\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrs\brdrw15
\clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth1040\clshdrawnil
\cellx5701\clvertalc\clbrdrt\brdrdb\brdrw15
\clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil
\cellx6040\clvertalc\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrs\brdrw15
\clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth341\clshdrawnil
\cellx6380\clvertalc\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrs\brdrw15
\clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil
\cellx6719\clvertalc\clbrdrt\brdrdb\brdrw15
\clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil
\cellx7058\clvertalc\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrs\brdrw15
\clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil
\cellx7397\clvertalc\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrs\brdrw15
\clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil
\cellx7736\clvertalc\clbrdrt\brdrdb\brdrw15
\clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil
\cellx8075\clvertalc\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrs\brdrw15
\clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil
\cellx8414\clvertalc\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrs\brdrw15
\clbrdrb\brdrs\brdrw15 \clbrdrr\brdrs\brdrw15
\cltxlrtb\clftsWidth3\clwWidth340\clshdrawnil
\cellx8753\clvertalc\clbrdrt\brdrdb\brdrw15
\clbrdrl\brdrs\brdrw15 \clbrdrb\brdrs\brdrw15 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth320\clshdrawnil \cellx9072\pard \ltrpar\ql
\li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adj
ustright\rin0\lin0\pararsid7872705 {
\rtlch\fcs1 \ab\af1\afs18 \ltrch\fcs0
\b\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16207100\charrsid1023090
2 Company name:\cell }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16207100\charrsid10230902
VAT No.:
\cell \cell \cell \cell \cell \cell \cell \cell \cell \cell \cell }\pard
\ltrpar\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16207100\charrsid10230902
\trowd
\irow0\irowband0\ltrrow\ts11\trgaph70\trrh284\trleft0\trkeep\trbrdrt\brdr
s\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15
\trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15
\trbrdrv\brdrs\brdrw15
\trftsWidth3\trwWidth9072\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\t
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\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16207100\charrsid10230902
Zip Code:\cell \cell \cell }\pard \ltrpar\qc
\li0\ri0\sb40\sa40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adj
ustright\rin0\lin0\pararsid7872705 {
\rtlch\fcs1 \ab\af1\afs18 \ltrch\fcs0
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2 -\cell }\pard \ltrpar\ql
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\cell \cell \cell \cell \cell \cell e-mail:\cell }\pard \ltrpar
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@\cell }\pard \ltrpar
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Banking with:\cell \cell Account No.:\cell \cell }\pard \ltrpar\ql
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IBAN:\cell \cell SWIFT Code:\cell \cell }\pard \ltrpar\ql
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\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16207100\charrsid10230902
Represented by:\cell }\pard \ltrpar\ql
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\trbrdrh
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Person authorized to negotiation:\cell }\pard \ltrpar\ql
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\par }{\rtlch\fcs1 \af1\afs20 \ltrch\fcs0
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\par }\pard\plain \ltrpar\ql
\li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\li
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P}{\rtlch\fcs1 \ab\af1\afs22 \ltrch\fcs0
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RODUCT}{\rtlch\fcs1 \ab\af1\afs22 \ltrch\fcs0
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Name of }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid15409547 the}{\rtlch\fcs1
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AIMD}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
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:}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid7948848 \line
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\cell }\pard \ltrpar
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\brdrs\brdrw15
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\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
Type/Model }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16725290 \endash please
write }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid15409547 the more detailed
specifications on the page 2}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
:}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid15409547
\par }\pard \ltrpar\ql
\li0\ri0\sb60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustri
ght\rin0\lin0 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid15409547\charrsid11546023
\cell }\pard \ltrpar
\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0 {\rtlch\fcs1 \af0\afs18 \ltrch\fcs0
\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\trowd \irow1\irowband1\ltrrow\ts11\trgaph70\trleft0\trkeep
\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15
\trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15
\trftsWidth3\trwWidth9072\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\t
rpaddfl3\trpaddfr3\tblind70\tblindtype3
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrdb\brdrw15
\clbrdrb\brdrs\brdrw10 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth9072\clshdrawnil \cellx9072\row
\ltrrow}\trowd
\irow2\irowband2\ltrrow\ts11\trgaph70\trleft0\trkeep\trbrdrt
\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15
\trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15
\trftsWidth3\trwWidth9072\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\t
rpaddfl3\trpaddfr3\tblind70\tblindtype3 \clvertalt
\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrdb\brdrw15
\clbrdrr\brdrnone \cltxlrtb\clftsWidth3\clwWidth6840\clshdrawnil
\cellx6840\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrnone
\clbrdrb\brdrdb\brdrw15 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth2232\clshdrawnil \cellx9072\pard \ltrpar\ql
\li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adj
ustright\rin0\lin0\pararsid7872705 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16725290\charrsid16725290
The}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16725290 product uses the
nuclear energy and/or ionizing radiation (radioactive) sources}{
\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid7948848 :}{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16725290\charrsid16725290
\cell }\pard \ltrpar
\ql
\li0\ri0\sb60\sa60\widctlpar\intbl\tx290\tx1370\wrapdefault\aspalpha\aspn
um\faauto\adjustright\rin0\lin0\pararsid7872705 {\rtlch\fcs1 \af1\afs18
\ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16725290\charrsid16725290
\tab }
{\field\flddirty\fldpriv{\*\fldinst {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16725290\charrsid16725290
FORMCHECKBOX }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid526294
{\*\datafield
65000000140000000c5a619a6b7274e1766163ed3200000000000000000000000000}{\*\
formfield{\fftype1\ffres25\fftypetxt0\ffhps20{\*\ffname
Za\'9akrt\'e1vac\'ed2}\ffdefres0}}}}{\fldrslt }}\sectd \ltrsect
\psz9\linex0\headery567\footery454\colsx708\endnhere\titlepg\pgbrdropt32\
sectlinegrid360\sectdefaultcl\sectrsid538236\sftnbj {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16725290\charrsid16725290
}{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16725290 yes}{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16725290\charrsid16725290
\tab }{\field\flddirty\fldpriv{\*\fldinst {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16725290\charrsid16725290
FORMCHECKBOX }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid526294 {\*\datafield
65000000140000000c5a619a6b7274e1766163ed3200000000000000000000000000}{\*\
formfield{\fftype1\ffres25\fftypetxt0\ffhps20{\*\ffname
Za\'9akrt\'e1vac\'ed2}\ffdefres0}}}}{\fldrslt }}\sectd \ltrsect
\psz9\linex0\headery567\footery454\colsx708\endnhere\titlepg\pgbrdropt32\
sectlinegrid360\sectdefaultcl\sectrsid538236\sftnbj {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16725290\charrsid16725290
n}{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16725290 o}{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16725290\charrsid16725290
\cell }\pard \ltrpar
\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0 {\rtlch\fcs1 \af0\afs18 \ltrch\fcs0
\fs18\lang2057\langfe1029\langnp2057\insrsid16725290\charrsid16725290
\trowd \irow2\irowband2\ltrrow\ts11\trgaph70\trleft0\trkeep
\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15
\trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15
\trftsWidth3\trwWidth9072\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\t
rpaddfl3\trpaddfr3\tblind70\tblindtype3
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrdb\brdrw15
\clbrdrb\brdrdb\brdrw15 \clbrdrr\brdrnone
\cltxlrtb\clftsWidth3\clwWidth6840\clshdrawnil
\cellx6840\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrnone
\clbrdrb\brdrdb\brdrw15 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth2232\clshdrawnil \cellx9072\row
\ltrrow}\trowd
\irow3\irowband3\ltrrow\ts11\trgaph70\trleft0\trkeep\trbrdrt\brdrs\brdrw1
5 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15
\trbrdrh\brdrs\brdrw15 \trbrdrv
\brdrs\brdrw15
\trftsWidth3\trwWidth9072\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\t
rpaddfl3\trpaddfr3\tblind70\tblindtype3 \clvertalt\clbrdrt\brdrdb\brdrw15
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth9072\clshdrawnil \cellx9072\pard \ltrpar\ql
\li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adj
ustright\rin0\lin0\pararsid15409547 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid15409547\charrsid10230902
Manufacturer\rquote s company name and address (if it differs from the
applicant):}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420
\par }\pard \ltrpar\ql
\li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adj
ustright\rin0\lin0 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid15409547\charrsid11546023
\cell }\pard \ltrpar
\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0 {\rtlch\fcs1 \af0\afs18 \ltrch\fcs0
\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\trowd \irow3\irowband3\ltrrow\ts11\trgaph70\trleft0\trkeep
\trbrdrt\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15
\trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15
\trftsWidth3\trwWidth9072\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\t
rpaddfl3\trpaddfr3\tblind70\tblindtype3
\clvertalt\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrdb\brdrw15
\clbrdrb\brdrs\brdrw10 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth9072\clshdrawnil \cellx9072\row
\ltrrow}\trowd \irow4\irowband4\lastrow
\ltrrow\ts11\trgaph70\trleft0\trkeep\trbrdrt
\brdrs\brdrw15 \trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15
\trbrdrr\brdrs\brdrw15 \trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15
\trftsWidth3\trwWidth9072\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\t
rpaddfl3\trpaddfr3\tblind70\tblindtype3 \clvertalt
\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrdb\brdrw15
\clbrdrr\brdrnone \cltxlrtb\clftsWidth3\clwWidth6840\clshdrawnil
\cellx6840\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrnone
\clbrdrb\brdrdb\brdrw15 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth2232\clshdrawnil \cellx9072\pard \ltrpar\ql
\li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adj
ustright\rin0\lin0 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
Is your company part of some larger organisation ?: (}{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid15409547 if yes,
}{\rtlch\fcs1 \af1\afs18
\ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
specify}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16725290 its
name}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023 )
\par \cell }\pard \ltrpar\ql
\li0\ri0\sb60\sa60\widctlpar\intbl\tx290\tx1370\wrapdefault\aspalpha\aspn
um\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\tab }
{\field\flddirty\fldpriv{\*\fldinst {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
FORMCHECKBOX }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid526294
{\*\datafield
65000000140000000c5a619a6b7274e1766163ed3200000000000000000000000000}{\*\
formfield{\fftype1\ffres25\fftypetxt0\ffhps20{\*\ffname
Za\'9akrt\'e1vac\'ed2}\ffdefres0}}}}{\fldrslt }}\sectd \ltrsect
\psz9\linex0\headery567\footery454\colsx708\endnhere\titlepg\pgbrdropt32\
sectlinegrid360\sectdefaultcl\sectrsid538236\sftnbj {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
}{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid15409547 yes}{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\tab }{\field\flddirty\fldpriv{\*\fldinst {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
FORMCHECKBOX }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid526294 {\*\datafield
65000000140000000c5a619a6b7274e1766163ed3200000000000000000000000000}{\*\
formfield{\fftype1\ffres25\fftypetxt0\ffhps20{\*\ffname
Za\'9akrt\'e1vac\'ed2}\ffdefres0}}}}{\fldrslt }}\sectd \ltrsect
\psz9\linex0\headery567\footery454\colsx708\endnhere\titlepg\pgbrdropt32\
sectlinegrid360\sectdefaultcl\sectrsid538236\sftnbj {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
n}{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid15409547 o}{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\cell }\pard \ltrpar
\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0 {\rtlch\fcs1 \af0\afs18 \ltrch\fcs0
\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\trowd \irow4\irowband4\lastrow \ltrrow
\ts11\trgaph70\trleft0\trkeep\trbrdrt\brdrs\brdrw15
\trbrdrl\brdrs\brdrw15 \trbrdrb\brdrs\brdrw15 \trbrdrr\brdrs\brdrw15
\trbrdrh\brdrs\brdrw15 \trbrdrv\brdrs\brdrw15
\trftsWidth3\trwWidth9072\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\t
rpaddfl3\trpaddfr3\tblind70\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrdb\brdrw15 \clbrdrr\brdrnone
\cltxlrtb\clftsWidth3\clwWidth6840\clshdrawnil
\cellx6840\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrnone
\clbrdrb\brdrdb\brdrw15 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth2232\clshdrawnil \cellx9072\row
}\pard\plain \ltrpar
\s15\ql
\li0\ri0\widctlpar\tx360\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0\itap0 \rtlch\fcs1 \af0\afs22\alang1025 \ltrch\fcs0
\fs22\lang1029\langfe1029\cgrid\langnp1029\langfenp1029 {\rtlch\fcs1
\af39\afs18 \ltrch\fcs0
\f39\fs18\lang2057\langfe1029\langnp2057\insrsid5400595
\par }\pard\plain \ltrpar\ql
\li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\li
n0\itap0\pararsid5400595 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0
\fs24\lang1029\langfe1029\cgrid\langnp1029\langfenp1029 {\rtlch\fcs1
\ab\af1\afs22
\ltrch\fcs0 \b\caps\f1\fs22\insrsid5400595 specification of the
conformity assessment procedure:
\par \ltrrow}\trowd \irow0\irowband0\ltrrow\ts11\trqc\trgaph70\trleft-
70\trbrdrt\brdrdb\brdrw10 \trbrdrl\brdrdb\brdrw10 \trbrdrb\brdrdb\brdrw10
\trbrdrr\brdrdb\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrdb\brdrw15
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrnone
\cltxlrtb\clftsWidth3\clwWidth4320\clshdrawnil \cellx4250
\clvertalt\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrnone \clbrdrb\brdrnone
\clbrdrr\brdrdb\brdrw15 \cltxlrtb\clftsWidth3\clwWidth4750\clshdrawnil
\cellx9000\pard \ltrpar
\ql
\li0\ri0\sb60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustri
ght\rin0\lin0\pararsid7872705 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid5400595
The chosen }{\rtlch\fcs1 \af1\afs18
\ltrch\fcs0 \f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595
conformity assessment procedure}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid4787036 \line according to
9}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16725290 0}{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid4787036 /}{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16725290 385}{
\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid4787036 /EC
Directive}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid4787036\charrsid5400595
:}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid5400595
\cell }\pard \ltrpar\ql
\li0\ri0\sb60\widctlpar\intbl\tx110\tx470\tx1550\wrapdefault\aspalpha\asp
num\faauto\adjustright\rin0\lin0\pararsid1992602 {\rtlch\fcs1 \af1\afs18
\ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid3027364
\tab }{\field\flddirty\fldpriv{\*\fldinst {\rtlch\fcs1 \af1\afs18
\ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid3027364
FORMCHECKBOX }{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid526294 {\*\datafield
65000000140000000c5a619a6b7274e1766163ed3200000000000000000000000000}{\*\
formfield{\fftype1\ffres25\fftypetxt0\ffhps20{\*\ffname
Za\'9akrt\'e1vac\'ed2}\ffdefres0}}}
}{\fldrslt }}\sectd
\ltrsect\psz9\linex0\headery567\footery454\colsx708\endnhere\titlepg\pgbr
dropt32\sectlinegrid360\sectdefaultcl\sectrsid538236\sftnbj {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid1992602\charrsid3027364
\tab Annex }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid3027364\charrsid3027364
2}{\rtlch\fcs1 \af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid15483925
\tab }{\rtlch\fcs1 \af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid3027364\charrsid3027364
{\*\bkmkstart texte}Complete quality assurance system}{\rtlch\fcs1
\af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid15483925
{\*\bkmkend texte}\cell }\pard \ltrpar\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid5400595
\trowd \irow0\irowband0\ltrrow\ts11\trqc\trgaph70\trleft-
70\trbrdrt\brdrdb\brdrw10 \trbrdrl\brdrdb\brdrw10 \trbrdrb\brdrdb\brdrw10
\trbrdrr\brdrdb\brdrw10 \trbrdrh\brdrs\brdrw10
\trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrdb\brdrw15
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrnone
\cltxlrtb\clftsWidth3\clwWidth4320\clshdrawnil
\cellx4250\clvertalt\clbrdrt\brdrdb\brdrw15 \clbrdrl\brdrnone
\clbrdrb\brdrnone \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth4750\clshdrawnil \cellx9000\row
\ltrrow}\trowd \irow1\irowband1\ltrrow
\ts11\trqc\trgaph70\trleft-70\trkeep\trbrdrt\brdrdb\brdrw10
\trbrdrl\brdrdb\brdrw10 \trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10
\trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrnone
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrnone
\cltxlrtb\clftsWidth3\clwWidth4320\clshdrawnil \cellx4250\clvertalt
\clbrdrt\brdrnone \clbrdrl\brdrnone \clbrdrb\brdrnone
\clbrdrr\brdrdb\brdrw15 \cltxlrtb\clftsWidth3\clwWidth4750\clshdrawnil
\cellx9000\pard \ltrpar\ql
\li0\ri0\sb40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustri
ght\rin0\lin0\pararsid7872705
{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid5400595
\cell }\pard \ltrpar\ql \li0\ri0\sb40\widctlpar\intbl
\tx110\tx470\tx1190\tx1550\wrapdefault\aspalpha\aspnum\faauto\adjustright
\rin0\lin0\pararsid1992602 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid3027364
\tab }{\field\flddirty\fldpriv{\*\fldinst {
\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid3027364
FORMCHECKBOX }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid526294 {\*\datafield
65000000140000000c5a619a6b7274e1766163ed3200000000000000000000000000}{\*\
formfield{\fftype1\ffres25\fftypetxt0\ffhps20{\*\ffname
Za\'9akrt\'e1vac\'ed2}\ffdefres0}}}}{\fldrslt }}\sectd \ltrsect
\psz9\linex0\headery567\footery454\colsx708\endnhere\titlepg\pgbrdropt32\
sectlinegrid360\sectdefaultcl\sectrsid538236\sftnbj {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid1992602\charrsid3027364
\tab Annex}{
\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid3027364\charrsid3027364
3+4}{\rtlch\fcs1 \af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid15483925
\tab }{\rtlch\fcs1 \af1\afs16
\ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid3027364\charrsid15483925
EC Type examination +EC Verification}{\rtlch\fcs1 \af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid15483925
\cell }\pard \ltrpar
\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0 {\rtlch\fcs1 \ab\af0\afs18 \ltrch\fcs0
\b\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid5400595
\trowd \irow1\irowband1\ltrrow
\ts11\trqc\trgaph70\trleft-70\trkeep\trbrdrt\brdrdb\brdrw10
\trbrdrl\brdrdb\brdrw10 \trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10
\trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrnone
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrnone
\cltxlrtb\clftsWidth3\clwWidth4320\clshdrawnil \cellx4250\clvertalt
\clbrdrt\brdrnone \clbrdrl\brdrnone \clbrdrb\brdrnone
\clbrdrr\brdrdb\brdrw15 \cltxlrtb\clftsWidth3\clwWidth4750\clshdrawnil
\cellx9000\row \ltrrow}\pard \ltrpar
\ql
\li0\ri0\sb40\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustri
ght\rin0\lin0\pararsid7872705 {\rtlch\fcs1 \af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid5400595
(}{\rtlch\fcs1 \af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid4787036 please,
}{\rtlch\fcs1 \af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid5400595 check
}{\rtlch\fcs1 \af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid4787036
off }{\rtlch\fcs1 \af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid5400595 the appropriate
box}{\rtlch\fcs1 \af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid5400595
)}{\rtlch\fcs1 \af1\afs18
\ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid5400595
\cell }\pard \ltrpar\ql
\li0\ri0\sb40\widctlpar\intbl\tx110\tx470\tx1190\tx1550\wrapdefault\aspal
pha\aspnum\faauto\adjustright\rin0\lin0\pararsid1992602 {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid9855747
\tab }{\field\flddirty\fldpriv{\*\fldinst {\rtlch\fcs1 \af1\afs18
\ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid9855747
 FORMCHECKBOX }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid526294 {\*\datafield
65000000140000000c5a619a6b7274e1766163ed3200000000000000000000000000}{\*\
formfield{\fftype1\ffres25\fftypetxt0\ffhps20{\*\ffname
Za\'9akrt\'e1vac\'ed2}\ffdefres0}}}}{\fldrslt }}\sectd
\ltrsect\psz9\linex0\headery567\footery454\colsx708\endnhere\titlepg\pgbr
dropt32\sectlinegrid360\sectdefaultcl\sectrsid538236\sftnbj {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid1992602\charrsid9855747
\tab Annex}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid3027364\charrsid9855747
3+5}{\rtlch\fcs1 \af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid15483925
\tab }{\rtlch\fcs1 \af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid1992602\charrsid15483925
EC Type examination +}{\rtlch\fcs1 \af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid3027364\charrsid3027364
Assurance of }{\rtlch\fcs1 \af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid3027364 \tab \tab \tab
\tab \tab \tab }{\rtlch\fcs1 \af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid3027364\charrsid3027364
production quality}{\rtlch\fcs1 \af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid15483925
\cell }\pard \ltrpar
\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0 {\rtlch\fcs1 \ab\af0\afs18 \ltrch\fcs0
\b\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid5400595
\trowd \irow2\irowband2\ltrrow
\ts11\trqc\trgaph70\trleft-70\trkeep\trbrdrt\brdrdb\brdrw10
\trbrdrl\brdrdb\brdrw10 \trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10
\trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrnone
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrnone
\cltxlrtb\clftsWidth3\clwWidth4320\clshdrawnil \cellx4250\clvertalt
\clbrdrt\brdrnone \clbrdrl\brdrnone \clbrdrb\brdrnone
\clbrdrr\brdrdb\brdrw15 \cltxlrtb\clftsWidth3\clwWidth4750\clshdrawnil
\cellx9000\row \ltrrow}\trowd
\irow3\irowband3\ltrrow\ts11\trqc\trgaph70\trleft-
70\trkeep\trbrdrt\brdrdb\brdrw10 \trbrdrl
\brdrdb\brdrw10 \trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10
\trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrdb\brdrw15 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrnone
\cltxlrtb\clftsWidth3\clwWidth4320\clshdrawnil
\cellx4250\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrnone
\clbrdrb\brdrs\brdrw10 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth4750\clshdrawnil
\cellx9000\pard \ltrpar\ql
\li0\ri0\sb60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustri
ght\rin0\lin0\pararsid7872705 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid5400595
\cell
}\pard \ltrpar\ql
\li0\ri0\sb60\widctlpar\intbl\tx110\tx470\tx985\tx1550\wrapdefault\aspalp
ha\aspnum\faauto\adjustright\rin0\lin0\pararsid1992602 {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid9855747
\tab }{\field\flddirty\fldpriv{\*\fldinst {\rtlch\fcs1 \af1\afs18
\ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid9855747
FORMCHECKBOX }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid526294
{\*\datafield
65000000140000000c5a619a6b7274e1766163ed3200000000000000000000000000}{\*\
formfield{\fftype1\ffres25\fftypetxt0\ffhps20{\*\ffname
Za\'9akrt\'e1vac\'ed2}\ffdefres0}}}}{\fldrslt }}\sectd \ltrsect
\psz9\linex0\headery567\footery454\colsx708\endnhere\titlepg\pgbrdropt32\
sectlinegrid360\sectdefaultcl\sectrsid538236\sftnbj {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid9855747
\tab }{\rtlch\fcs1
\af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid10175014 \tab
}{\rtlch\fcs1 \af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid4787036\charrsid4787036
Another requirement}{\rtlch\fcs1 \af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid4787036
(}{\rtlch\fcs1 \af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid4787036\charrsid4787036
please, specify}{\rtlch\fcs1 \af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid4787036
):\line \tab \tab \cell }\pard \ltrpar\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0 {\rtlch\fcs1 \ab\af0\afs18 \ltrch\fcs0
\b\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid5400595
\trowd \irow3\irowband3\ltrrow\ts11\trqc\trgaph70\trleft-
70\trkeep\trbrdrt\brdrdb\brdrw10 \trbrdrl\brdrdb\brdrw10
\trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10 \trbrdrh\brdrs\brdrw10
\trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrnone
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrnone
\cltxlrtb\clftsWidth3\clwWidth4320\clshdrawnil
\cellx4250\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrnone
\clbrdrb\brdrs\brdrw10 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth4750\clshdrawnil \cellx9000\row
\ltrrow}\trowd \irow4\irowband4\ltrrow
\ts11\trqc\trgaph70\trleft-70\trbrdrt\brdrdb\brdrw10
\trbrdrl\brdrdb\brdrw10 \trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10
\trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrnone
\cltxlrtb\clftsWidth3\clwWidth4320\clshdrawnil \cellx4250
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrnone \clbrdrb\brdrs\brdrw10
\clbrdrr\brdrdb\brdrw15 \cltxlrtb\clftsWidth3\clwWidth4750\clshdrawnil
\cellx9000\pard \ltrpar\ql \li0\ri0\sb60\sa60\widctlpar\intbl
\tx290\tx1550\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0\pa
rarsid7872705 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid4787036\charrsid11546023
Are you interested in guidance }{\rtlch\fcs1 \af1\afs18
\ltrch\fcs0 \f1\fs18\lang2057\langfe1029\langnp2057\insrsid4787036
on}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid4787036\charrsid11546023
the conformity assessment procedure according to }{\rtlch\fcs1 \af1\afs18
\ltrch\fcs0 \f1\fs18\lang2057\langfe1029\langnp2057\insrsid4787036
9}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid3027364
0/385/EEC}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid5400595
\cell }\pard \ltrpar\ql
\li0\ri0\sb60\sa60\widctlpar\intbl\tx110\tx290\tx470\tx1190\wrapdefault\a
spalpha\aspnum\faauto\adjustright\rin0\lin0\pararsid1992602 {\rtlch\fcs1
\af1\afs18
\ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid9855747
\tab }{\field\flddirty\fldpriv{\*\fldinst {\rtlch\fcs1 \af1\afs18
\ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid9855747
FORMCHECKBOX }{
\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid526294 {\*\datafield
65000000140000000c5a619a6b7274e1766163ed3200000000000000000000000000}{\*\
formfield{\fftype1\ffres25\fftypetxt0\ffhps20{\*\ffname
Za\'9akrt\'e1vac\'ed2}
\ffdefres0}}}}{\fldrslt }}\sectd
\ltrsect\psz9\linex0\headery567\footery454\colsx708\endnhere\titlepg\pgbr
dropt32\sectlinegrid360\sectdefaultcl\sectrsid538236\sftnbj {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid9855747
}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid4787036\charrsid9855747
yes}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid9855747
\tab }{\field\flddirty\fldpriv{\*\fldinst {\rtlch\fcs1 \af1\afs18
\ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid9855747
FORMCHECKBOX }{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid526294 {\*\datafield
65000000140000000c5a619a6b7274e1766163ed3200000000000000000000000000}{\*\
formfield{\fftype1\ffres25\fftypetxt0\ffhps20{\*\ffname
Za\'9akrt\'e1vac\'ed2}\ffdefres0}}}
}{\fldrslt }}\sectd
\ltrsect\psz9\linex0\headery567\footery454\colsx708\endnhere\titlepg\pgbr
dropt32\sectlinegrid360\sectdefaultcl\sectrsid538236\sftnbj {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid9855747
}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid4787036\charrsid9855747
no}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid9855747
\cell }\pard \ltrpar\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0 {\rtlch\fcs1 \ab\af0\afs18 \ltrch\fcs0
\b\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid5400595
\trowd \irow4\irowband4\ltrrow\ts11\trqc\trgaph70\trleft-
70\trbrdrt\brdrdb\brdrw10 \trbrdrl\brdrdb\brdrw10 \trbrdrb\brdrdb\brdrw10
\trbrdrr\brdrdb\brdrw10 \trbrdrh\brdrs\brdrw10
\trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrnone
\cltxlrtb\clftsWidth3\clwWidth4320\clshdrawnil
\cellx4250\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrnone
\clbrdrb\brdrs\brdrw10 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth4750\clshdrawnil \cellx9000\row \ltrrow
}\trowd \irow5\irowband5\lastrow \ltrrow\ts11\trqc\trgaph70\trleft-
70\trbrdrt\brdrdb\brdrw10 \trbrdrl\brdrdb\brdrw10 \trbrdrb\brdrdb\brdrw10
\trbrdrr\brdrdb\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrdb\brdrw10 \clbrdrr\brdrnone
\cltxlrtb\clftsWidth3\clwWidth4320\clshdrawnil \cellx4250
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrnone
\clbrdrb\brdrdb\brdrw10 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth4750\clshdrawnil \cellx9000\pard \ltrpar
\ql
\li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adj
ustright\rin0\lin0\pararsid7872705 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid10175014
Require}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid3027364 d}{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid10175014 language
versions of issued certificates}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid5400595
\cell }\pard \ltrpar\ql
\li0\ri0\sb60\sa60\widctlpar\intbl\tx110\tx470\tx1190\tx1910\wrapdefault\
aspalpha\aspnum\faauto\adjustright\rin0\lin0\pararsid9855747 {\rtlch\fcs1
\af1\afs18
\ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid9855747
\tab }{\field\flddirty\fldpriv{\*\fldinst {\rtlch\fcs1 \af1\afs18
\ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid9855747
FORMCHECKBOX }{
\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid526294 {\*\datafield
65000000140000000c5a619a6b7274e1766163ed3200000000000000000000000000}{\*\
formfield{\fftype1\ffres25\fftypetxt0\ffhps20{\*\ffname
Za\'9akrt\'e1vac\'ed2}
\ffdefres0}}}}{\fldrslt }}\sectd
\ltrsect\psz9\linex0\headery567\footery454\colsx708\endnhere\titlepg\pgbr
dropt32\sectlinegrid360\sectdefaultcl\sectrsid538236\sftnbj {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid9855747
}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid10175014\charrsid9855747
Czech}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid9855747
\tab }{\field\flddirty\fldpriv{\*\fldinst {\rtlch\fcs1 \af1\afs18
\ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid9855747
FORMCHECKBOX }{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid526294 {\*\datafield
65000000140000000c5a619a6b7274e1766163ed3200000000000000000000000000}{\*\
formfield{\fftype1\ffres25\fftypetxt0\ffhps20{\*\ffname
Za\'9akrt\'e1vac\'ed2}\ffdefres0}}}
}{\fldrslt }}\sectd
\ltrsect\psz9\linex0\headery567\footery454\colsx708\endnhere\titlepg\pgbr
dropt32\sectlinegrid360\sectdefaultcl\sectrsid538236\sftnbj {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid9855747
}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid10175014\charrsid9855747
English}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid9855747 \tab
}{\field\flddirty\fldpriv{\*\fldinst {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid9855747
FORMCHECKBOX }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid526294 {\*\datafield
65000000140000000c5a619a6b7274e1766163ed3200000000000000000000000000}{\*\
formfield{\fftype1\ffres25\fftypetxt0\ffhps20{\*\ffname
Za\'9akrt\'e1vac\'ed2}\ffdefres0}}}}{\fldrslt }}
\sectd
\ltrsect\psz9\linex0\headery567\footery454\colsx708\endnhere\titlepg\pgbr
dropt32\sectlinegrid360\sectdefaultcl\sectrsid538236\sftnbj {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid15274941\charrsid9855747
}{
\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid10175014\charrsid9855747
other}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid9855747 (
)\cell
}\pard \ltrpar\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0 {\rtlch\fcs1 \ab\af0\afs18 \ltrch\fcs0
\b\fs18\lang2057\langfe1029\langnp2057\insrsid5400595\charrsid5400595
\trowd \irow5\irowband5\lastrow \ltrrow
\ts11\trqc\trgaph70\trleft-70\trbrdrt\brdrdb\brdrw10
\trbrdrl\brdrdb\brdrw10 \trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10
\trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrdb\brdrw10 \clbrdrr\brdrnone
\cltxlrtb\clftsWidth3\clwWidth4320\clshdrawnil \cellx4250
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrnone
\clbrdrb\brdrdb\brdrw10 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth4750\clshdrawnil \cellx9000\row }\pard
\ltrpar
\ql
\li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\li
n0\itap0\pararsid7164328 {\rtlch\fcs1 \ab\af0\afs12 \ltrch\fcs0
\b\fs12\lang2057\langfe1029\langnp2057\insrsid7164328\charrsid10230902
\par }{\rtlch\fcs1 \ab\af1\afs18 \ltrch\fcs0
\b\f1\fs18\lang2057\langfe1029\langnp2057\insrsid7164328\charrsid10230902
Applicant\rquote s declaration:}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid7164328\charrsid10230902

\par {\pntext\pard\plain\ltrpar \rtlch\fcs1 \ai\af0\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid7164328\charrsid10230902
\hich\af1\dbch\af0\loch\f1 1.\tab}}\pard \ltrpar\ql \fi-
357\li357\ri0\sb120\widctlpar\tx360\wrapdefault{\*\pn
\pnlvlbody\ilvl0\ls8\pnrnot0\pndec\pnstart1\pnindent360\pnhang {\pntxta
.}}\aspalpha\aspnum\faauto\ls8\adjustright\rin0\lin357\itap0\pararsid7088
162 {\rtlch\fcs1 \ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid7164328\charrsid10230902
We }{\rtlch\fcs1 \ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid7164328 agree that
product samples }{\rtlch\fcs1 \ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid9896468 will not be
returned after assessment}{\rtlch\fcs1 \ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid7164328\charrsid10230902
.}{\rtlch\fcs1 \ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid7164328
\par {\pntext\pard\plain\ltrpar \rtlch\fcs1 \ai\af0\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid3871440\charrsid16126632
\hich\af1\dbch\af0\loch\f1 2.\tab}}\pard \ltrpar\ql \fi-
360\li360\ri0\widctlpar\tx360\wrapdefault{\*\pn
\pnlvlbody\ilvl0\ls8\pnrnot0\pndec\pnstart1\pnindent360\pnhang {\pntxta
.}}\aspalpha\aspnum\faauto\ls8\adjustright\rin0\lin360\itap0\pararsid3871
440 {\rtlch\fcs1 \ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid3871440\charrsid16126632
We declare that }{\rtlch\fcs1 \ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid3871440 we did not
submit}{\rtlch\fcs1 \ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid3871440\charrsid1908595
}{\rtlch\fcs1 \ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid3871440
similar}{\rtlch\fcs1 \ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid3871440\charrsid16126632
application for the same product}{\rtlch\fcs1 \ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid3871440 }{\rtlch\fcs1
\ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid3871440\charrsid16126632
to any other }{\rtlch\fcs1 \ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid3871440 notified
}{\rtlch\fcs1 \ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid3871440\charrsid16126632
bod}{\rtlch\fcs1 \ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid3871440 y.}{\rtlch\fcs1
\ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid7164328
\par {\pntext\pard\plain\ltrpar \rtlch\fcs1 \ai\af0\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16581448
\hich\af1\dbch\af0\loch\f1 3.\tab}}\pard \ltrpar\ql \fi-
360\li360\ri0\widctlpar\tx360\wrapdefault{\*\pn
\pnlvlbody\ilvl0\ls8\pnrnot0
\pndec\pnstart1\pnindent360\pnhang {\pntxta
.}}\aspalpha\aspnum\faauto\ls8\adjustright\rin0\lin360\itap0\pararsid3871
440 {\rtlch\fcs1 \ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16581448 We
agree}{\rtlch\fcs1 \ai\af1\afs18
\ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16581448\charrsid1658144
8 with the }{\rtlch\fcs1 \ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid2570173
\'93}{\rtlch\fcs1 \ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16581448\charrsid1658144
8 Obligatory }{\rtlch\fcs1 \ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16581448 B}{\rtlch\fcs1
\ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16581448\charrsid1658144
8 usiness }{\rtlch\fcs1 \ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16581448 C}{\rtlch\fcs1
\ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16581448\charrsid1658144
8 o}{\rtlch\fcs1 \ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid2570173 nditions\'94 of
ITC and we will abide by them}{\rtlch\fcs1 \ai\af1\afs18
\ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16581448\charrsid1658144
8 .}{\rtlch\fcs1 \ai\af1\afs18 \ltrch\fcs0
\i\f1\fs18\lang2057\langfe1029\langnp2057\insrsid16581448
\par }\pard \ltrpar\ql
\li0\ri0\widctlpar\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\li
n0\itap0\pararsid7164328 {\rtlch\fcs1 \af0\afs12 \ltrch\fcs0
\fs12\lang2057\langfe1029\langnp2057\insrsid7164328
\par }{\rtlch\fcs1 \af0\afs12 \ltrch\fcs0
\fs12\lang2057\langfe1029\langnp2057\insrsid16597048\charrsid10230902
\par }{\rtlch\fcs1 \af0\afs12 \ltrch\fcs0
\fs12\lang2057\langfe1029\langnp2057\insrsid7948848\charrsid7164328
\par }\pard \ltrpar\ql
\li0\ri0\widctlpar\tx4320\wrapdefault\aspalpha\aspnum\faauto\adjustright\
rin0\lin0\itap0\pararsid7164328 {\rtlch\fcs1 \af0 \ltrch\fcs0
\lang1024\langfe1024\noproof\insrsid526294
{\shp{\*\shpinst\shpleft5220\shptop179\shpright9000\shpbottom179\shpfhdr0
\shpbxcolumn\shpbxignore\shpbypara\shpbyignore\shpwr3\shpwrk0\shpfblwtxt0
\shpz0\shplid1026{\sp{\sn shapeType}{\sv 20}}{\sp{\sn fFlipH}{\sv
0}}{\sp{\sn fFlipV}{\sv 0}}
{\sp{\sn shapePath}{\sv 4}}{\sp{\sn fFillOK}{\sv 0}}{\sp{\sn fFilled}{\sv
0}}{\sp{\sn lineDashing}{\sv 2}}{\sp{\sn lineEndCapStyle}{\sv 0}}{\sp{\sn
fArrowheadsOK}{\sv 1}}{\sp{\sn fLine}{\sv 1}}{\sp{\sn dhgt}{\sv
251657216}}{\sp{\sn fLayoutInCell}{\sv 1}}
{\sp{\sn fPseudoInline}{\sv 0}}{\sp{\sn fLayoutInCell}{\sv
1}}}{\shprslt{\*\do\dobxcolumn\dobypara\dodhgt8192\dpline\dpptx0\dppty0\d
pptx3780\dppty0\dplinedot\dpx5220\dpy179\dpxsize3780\dpysize0\dplinew15\d
plinecor0\dplinecog0\dplinecob0}}}
{\shp{\*\shpinst\shpleft0\shptop179\shpright1800\shpbottom179\shpfhdr0\sh
pbxcolumn\shpbxignore\shpbypara\shpbyignore\shpwr3\shpwrk0\shpfblwtxt0\sh
pz1\shplid1027{\sp{\sn shapeType}{\sv 20}}{\sp{\sn fFlipH}{\sv
0}}{\sp{\sn fFlipV}{\sv 0}}
{\sp{\sn shapePath}{\sv 4}}{\sp{\sn fFillOK}{\sv 0}}{\sp{\sn fFilled}{\sv
0}}{\sp{\sn lineDashing}{\sv 2}}{\sp{\sn lineEndCapStyle}{\sv 0}}{\sp{\sn
fArrowheadsOK}{\sv 1}}{\sp{\sn fLine}{\sv 1}}{\sp{\sn dhgt}{\sv
251658240}}{\sp{\sn fLayoutInCell}{\sv 1}}
{\sp{\sn fPseudoInline}{\sv 0}}{\sp{\sn fLayoutInCell}{\sv
1}}}{\shprslt{\*\do\dobxcolumn\dobypara\dodhgt8193\dpline\dpptx0\dppty0\d
pptx1800\dppty0\dplinedot\dpx0\dpy179\dpxsize1800\dpysize0\dplinew15\dpli
necor0\dplinecog0\dplinecob0}}}}{\rtlch\fcs1
\ab\af1\afs20 \ltrch\fcs0
\b\f1\fs20\lang2057\langfe1029\langnp2057\insrsid7164328\charrsid10230902
\par }\pard \ltrpar\ql
\li0\ri0\widctlpar\tx5400\wrapdefault\aspalpha\aspnum\faauto\adjustright\
rin0\lin0\itap0\pararsid7164328 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid7164328\charrsid10230902
}{\rtlch\fcs1
\af1\afs16 \ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid7164328\charrsid10230902
Date of Application}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid7164328\charrsid10230902
\tab }{\rtlch\fcs1 \af1\afs16
\ltrch\fcs0
\f1\fs16\lang2057\langfe1029\langnp2057\insrsid7164328\charrsid10230902
Stamp and signature of applicant\rquote s representative}{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid7164328\charrsid10230902

\par }\pard \ltrpar\ql
\li0\ri0\widctlpar\tx5400\wrapdefault\aspalpha\aspnum\faauto\adjustright\
rin0\lin0\itap0 {\rtlch\fcs1 \ab\af1\afs28 \ltrch\fcs0
\b\f1\fs28\lang2057\langfe1029\langnp2057\insrsid355891\charrsid355891
Detailed}{\rtlch\fcs1 \ab\af1\afs28
\ltrch\fcs0
\b\f1\fs28\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid355891
specification of the }{\rtlch\fcs1 \ab\af1\afs28 \ltrch\fcs0
\b\f1\fs28\lang2057\langfe1029\langnp2057\insrsid1512247 Active
Implantable}{\rtlch\fcs1 \ab\af1\afs28
\ltrch\fcs0
\b\f1\fs28\lang2057\langfe1029\langnp2057\insrsid355891\charrsid355891
Medical Device }{\rtlch\fcs1 \ab\af1\afs28 \ltrch\fcs0
\b\f1\fs28\lang2057\langfe1029\langnp2057\insrsid1512247
AIMD}{\rtlch\fcs1 \ab\af1\afs28 \ltrch\fcs0
\b\f1\fs28\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid355891
}{\rtlch\fcs1 \ab\af1\afs28 \ltrch\fcs0
\b\f1\fs28\lang2057\langfe1029\langnp2057\insrsid355891\charrsid355891
submitted to conformity assessment}{\rtlch\fcs1 \ab\ai\af1\afs28
\ltrch\fcs0
\b\i\f1\fs28\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid355891
:}{\rtlch\fcs1 \ab\af1\afs28 \ltrch\fcs0
\b\f1\fs28\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid355891
\par }{\rtlch\fcs1 \af1\afs8 \ltrch\fcs0
\f1\fs8\lang2057\langfe1029\langnp2057\insrsid5906420
\par }{\rtlch\fcs1 \af1\afs8 \ltrch\fcs0
\f1\fs8\lang2057\langfe1029\langnp2057\insrsid355891\charrsid11546023
\par \ltrrow}\trowd \irow0\irowband0\ltrrow\ts11\trqc\trgaph70\trleft-
70\trkeep\trbrdrt\brdrdb\brdrw10 \trbrdrl\brdrdb\brdrw10
\trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10 \trbrdrh\brdrs\brdrw10
\trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrdb\brdrw15
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth9070\clshdrawnil
\cellx9000\pard \ltrpar\ql
\li0\ri0\sb60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustri
ght\rin0\lin0 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
Name and description of the product:
\par
\par
\par }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420
\par }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid14491951\charrsid11546023
\par }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\cell }\pard \ltrpar\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\trowd \irow0\irowband0\ltrrow\ts11\trqc\trgaph70\trleft-
70\trkeep\trbrdrt\brdrdb\brdrw10 \trbrdrl\brdrdb\brdrw10
\trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10 \trbrdrh
\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrdb\brdrw15
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth9070\clshdrawnil \cellx9000\row
\ltrrow}\trowd \irow1\irowband1\ltrrow\ts11\trqc\trgaph70\trleft-
70\trkeep\trbrdrt\brdrdb\brdrw10 \trbrdrl\brdrdb\brdrw10
\trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10 \trbrdrh\brdrs\brdrw10
\trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth9070\clshdrawnil \cellx9000\pard\plain
\ltrpar\s18\ql
\li0\ri0\sb60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustri
ght\rin0\lin0 \rtlch\fcs1 \af1\afs18\alang1025 \ltrch\fcs0
\f1\fs18\lang1029\langfe1029\cgrid\langnp1029\langfenp1029 {\rtlch\fcs1
\af1 \ltrch\fcs0
\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023 List of
documentation enclosed (}{\rtlch\fcs1 \ai\af1 \ltrch\fcs0
\i\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023 figure,
drawing, instruction for use & }{\rtlch\fcs1 \ai\af1 \ltrch\fcs0
\i\lang2057\langfe1029\langnp2057\insrsid355891\charrsid11546023
installation}{\rtlch\fcs1 \ai\af1 \ltrch\fcs0
\i\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023 ,
technical specification }{\rtlch\fcs1 \ai\af1 \ltrch\fcs0
\i\lang2057\langfe1029\langnp2057\insrsid355891 etc.}{\rtlch\fcs1 \af1
\ltrch\fcs0
\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023 )
}{\rtlch\fcs1 \af1 \ltrch\fcs0
\lang2057\langfe1029\langnp2057\insrsid355891 as specified in the Annexes
of the 9}{\rtlch\fcs1 \af1 \ltrch\fcs0
\lang2057\langfe1029\langnp2057\insrsid7948848 0/385/EEC}{\rtlch\fcs1
\af1 \ltrch\fcs0 \lang2057\langfe1029\langnp2057\insrsid355891
directive}{\rtlch\fcs1 \af1 \ltrch\fcs0
\lang2057\langfe1029\langnp2057\insrsid7948848 as amended}{\rtlch\fcs1
\af1
\ltrch\fcs0
\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023 :
\par }\pard\plain \ltrpar\ql
\li0\ri0\sb60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustri
ght\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0
\fs24\lang1029\langfe1029\cgrid\langnp1029\langfenp1029 {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\par
\par
\par
\par \cell }\pard \ltrpar\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\trowd \irow1\irowband1\ltrrow
\ts11\trqc\trgaph70\trleft-70\trkeep\trbrdrt\brdrdb\brdrw10
\trbrdrl\brdrdb\brdrw10 \trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10
\trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth9070\clshdrawnil
\cellx9000\row \ltrrow}\pard \ltrpar\ql
\li0\ri0\sb60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustri
ght\rin0\lin0 {\rtlch\fcs1 \af1\afs20 \ltrch\fcs0
\f1\fs20\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
Intended use of the product (}{\rtlch\fcs1 \ai\af1\afs20 \ltrch\fcs0
\i\f1\fs20\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
detailed description}{\rtlch\fcs1 \af1\afs20 \ltrch\fcs0
\f1\fs20\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
):}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\par
\par
\par
\par
\par \cell }\pard \ltrpar\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\trowd \irow2\irowband2\ltrrow
\ts11\trqc\trgaph70\trleft-70\trkeep\trbrdrt\brdrdb\brdrw10
\trbrdrl\brdrdb\brdrw10 \trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10
\trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth9070\clshdrawnil
\cellx9000\row \ltrrow}\trowd
\irow3\irowband3\ltrrow\ts11\trqc\trgaph70\trleft-
70\trkeep\trbrdrt\brdrdb\brdrw10 \trbrdrl\brdrdb\brdrw10
\trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10 \trbrdrh\brdrs\brdrw10
\trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10
\cltxlrtb\clftsWidth3\clwWidth6300\clshdrawnil \cellx6230
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone
\clbrdrr\brdrdb\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2770\clshdrawnil
\cellx9000\pard \ltrpar
\ql
\li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adj
ustright\rin0\lin0 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid355891 Has been
}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
th}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid355891 is}{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid7948848 AIMD}{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420 }{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
product }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid355891 placed
}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
on the market }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid355891\charrsid11546023
already}{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
?\cell }\pard \ltrpar\ql \li0\ri0\sb60\sa60\widctlpar\intbl
\tx290\tx1550\wrapdefault\aspalpha\aspnum\faauto\adjustright\rin0\lin0
{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\tab }{\field\flddirty\fldpriv{\*\fldinst {\rtlch\fcs1 \af1\afs18
\ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
FORMCHECKBOX }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid526294 {\*\datafield
65000000140000000c5a619a6b7274e1766163ed3200000000000000000000000000}{\*\
formfield{\fftype1\ffres25\fftypetxt0\ffhps20{\*\ffname
Za\'9akrt\'e1vac\'ed2}\ffdefres0}}}}{\fldrslt }}\sectd \ltrsect
\psz9\linex0\headery567\footery454\colsx708\endnhere\titlepg\pgbrdropt32\
sectlinegrid360\sectdefaultcl\sectrsid538236\sftnbj {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
Yes\tab }
{\field\flddirty\fldpriv{\*\fldinst {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
FORMCHECKBOX }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid526294
{\*\datafield
65000000140000000c5a619a6b7274e1766163ed3200000000000000000000000000}{\*\
formfield{\fftype1\ffres25\fftypetxt0\ffhps20{\*\ffname
Za\'9akrt\'e1vac\'ed2}\ffdefres0}}}}{\fldrslt }}\sectd \ltrsect
\psz9\linex0\headery567\footery454\colsx708\endnhere\titlepg\pgbrdropt32\
sectlinegrid360\sectdefaultcl\sectrsid538236\sftnbj {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
No\cell
}\pard \ltrpar\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0 {\rtlch\fcs1 \ab\af0\afs18 \ltrch\fcs0
\b\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\trowd \irow3\irowband3\ltrrow
\ts11\trqc\trgaph70\trleft-70\trkeep\trbrdrt\brdrdb\brdrw10
\trbrdrl\brdrdb\brdrw10 \trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10
\trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10
\cltxlrtb\clftsWidth3\clwWidth6300\clshdrawnil \cellx6230
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone
\clbrdrr\brdrdb\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2770\clshdrawnil
\cellx9000\row \ltrrow}\trowd
\irow4\irowband4\ltrrow\ts11\trqc\trgaph70\trleft-70\trkeep\trbrdrt
\brdrdb\brdrw10 \trbrdrl\brdrdb\brdrw10 \trbrdrb\brdrdb\brdrw10
\trbrdrr\brdrdb\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt
\brdrnone \clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrnone
\clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth6300\clshdrawnil
\cellx6230\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw10
\clbrdrb\brdrnone \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth2770\clshdrawnil \cellx9000\pard \ltrpar\ql
\li0\ri0\sb60\sa60\widctlpar\intbl\tx470\wrapdefault\aspalpha\aspnum\faau
to\adjustright\rin0\lin0 {\rtlch\fcs1 \af1\afs20 \ltrch\fcs0
\f1\fs20\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
If yes, when }{\rtlch\fcs1 \af1\afs20 \ltrch\fcs0
\f1\fs20\lang2057\langfe1029\langnp2057\insrsid5906420 has
been}{\rtlch\fcs1 \af1\afs20 \ltrch\fcs0
\f1\fs20\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
the}{\rtlch\fcs1 \af1\afs20 \ltrch\fcs0
\f1\fs20\lang2057\langfe1029\langnp2057\insrsid7948848 AIMD}{\rtlch\fcs1
\af1\afs20 \ltrch\fcs0
\f1\fs20\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
introduced on the market:\cell }\pard \ltrpar\ql
\li0\ri0\sb60\sa60\widctlpar\intbl\tx290\tx1550\wrapdefault\aspalpha\aspn
um\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af1\afs18
\ltrch\fcs0 \f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420 \tab
In year }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\cell }\pard \ltrpar
\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0 {\rtlch\fcs1 \ab\af0\afs18 \ltrch\fcs0
\b\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\trowd \irow4\irowband4\ltrrow
\ts11\trqc\trgaph70\trleft-70\trkeep\trbrdrt\brdrdb\brdrw10
\trbrdrl\brdrdb\brdrw10 \trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10
\trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrnone
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10
\cltxlrtb\clftsWidth3\clwWidth6300\clshdrawnil \cellx6230
\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone
\clbrdrr\brdrdb\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2770\clshdrawnil
\cellx9000\row \ltrrow}\trowd
\irow5\irowband5\ltrrow\ts11\trqc\trgaph70\trleft-
70\trkeep\trbrdrt\brdrdb\brdrw10
\trbrdrl\brdrdb\brdrw10 \trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10
\trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrnone \clbrdrl
\brdrdb\brdrw15 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10
\cltxlrtb\clftsWidth3\clwWidth6300\clshdrawnil
\cellx6230\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw10
\clbrdrb\brdrs\brdrw10 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth2770\clshdrawnil \cellx9000\pard\plain
\ltrpar\s18\ql
\li0\ri0\sb60\sa60\widctlpar\intbl\tx470\wrapdefault\aspalpha\aspnum\faau
to\adjustright\rin0\lin0 \rtlch\fcs1 \af1\afs18\alang1025 \ltrch\fcs0
\f1\fs18\lang1029\langfe1029\cgrid\langnp1029\langfenp1029 {\rtlch\fcs1
\af1 \ltrch\fcs0
\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023 If yes,
which countries }{\rtlch\fcs1 \af1 \ltrch\fcs0
\lang2057\langfe1029\langnp2057\insrsid5906420
has been}{\rtlch\fcs1 \af1 \ltrch\fcs0
\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
the}{\rtlch\fcs1 \af1 \ltrch\fcs0
\lang2057\langfe1029\langnp2057\insrsid7948848 AIMD}{\rtlch\fcs1 \af1
\ltrch\fcs0
\lang2057\langfe1029\langnp2057\insrsid5906420 placed}{\rtlch\fcs1 \af1
\ltrch\fcs0
\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023 on the
market}{\rtlch\fcs1 \af1 \ltrch\fcs0
\lang2057\langfe1029\langnp2057\insrsid5906420 in}{
\rtlch\fcs1 \af1 \ltrch\fcs0
\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023 ?
\par }\pard\plain \ltrpar\ql
\li0\ri0\sb60\sa60\widctlpar\intbl\tx470\wrapdefault\aspalpha\aspnum\faau
to\adjustright\rin0\lin0 \rtlch\fcs1 \af0\afs24\alang1025 \ltrch\fcs0
\fs24\lang1029\langfe1029\cgrid\langnp1029\langfenp1029 {\rtlch\fcs1
\af1\afs18
\ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\cell }\pard \ltrpar\ql
\li0\ri0\sb60\sa60\widctlpar\intbl\tx290\tx1550\wrapdefault\aspalpha\aspn
um\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\cell }\pard \ltrpar\ql
\li0\ri0\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adjustright\r
in0\lin0 {\rtlch\fcs1 \ab\af0\afs18 \ltrch\fcs0
\b\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\trowd \irow5\irowband5\ltrrow\ts11\trqc\trgaph70\trleft-
70\trkeep\trbrdrt\brdrdb\brdrw10 \trbrdrl\brdrdb\brdrw10
\trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10 \trbrdrh
\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrnone
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10
\cltxlrtb\clftsWidth3\clwWidth6300\clshdrawnil
\cellx6230\clvertalt\clbrdrt\brdrnone \clbrdrl\brdrs\brdrw10
\clbrdrb\brdrs\brdrw10 \clbrdrr\brdrdb\brdrw15
\cltxlrtb\clftsWidth3\clwWidth2770\clshdrawnil \cellx9000\row
\ltrrow}\trowd \irow6\irowband6\ltrrow
\ts11\trqc\trgaph70\trleft-70\trkeep\trbrdrt\brdrdb\brdrw10
\trbrdrl\brdrdb\brdrw10 \trbrdrb\brdrdb\brdrw10 \trbrdrr\brdrdb\brdrw10
\trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10
\trftsWidth1\trftsWidthB3\trftsWidthA3\trpaddl70\trpaddr70\trpaddfl3\trpa
ddfr3\tblind0\tblindtype3 \clvertalt\clbrdrt\brdrs\brdrw10
\clbrdrl\brdrdb\brdrw15 \clbrdrb\brdrnone \clbrdrr\brdrs\brdrw10
\cltxlrtb\clftsWidth3\clwWidth6300\clshdrawnil \cellx6230
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrnone
\clbrdrr\brdrdb\brdrw15 \cltxlrtb\clftsWidth3\clwWidth2770\clshdrawnil
\cellx9000\pard \ltrpar
\ql
\li0\ri0\sb60\sa60\widctlpar\intbl\wrapdefault\aspalpha\aspnum\faauto\adj
ustright\rin0\lin0 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
Is the device designed and manufactured in}{
\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420 a }{\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
controlled quality system?\cell }\pard \ltrpar
\ql
\li0\ri0\sb60\sa60\widctlpar\intbl\tx290\tx1550\wrapdefault\aspalpha\aspn
um\faauto\adjustright\rin0\lin0 {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
\tab }
{\field\flddirty\fldpriv{\*\fldinst {\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
FORMCHECKBOX }{\rtlch\fcs1 \af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid526294
{\*\datafield
65000000140000000c5a619a6b7274e1766163ed3200000000000000000000000000}{\*\
formfield{\fftype1\ffres25\fftypetxt0\ffhps20{\*\ffname
Za\'9akrt\'e1vac\'ed2}\ffdefres0}}}}{\fldrslt }}\sectd \ltrsect
\psz9\linex0\headery567\footery454\colsx708\endnhere\titlepg\pgbrdropt32\
sectlinegrid360\sectdefaultcl\sectrsid538236\sftnbj {\rtlch\fcs1
\af1\afs18 \ltrch\fcs0
\f1\fs18\lang2057\langfe1029\langnp2057\insrsid5906420\charrsid11546023
Yes\tab }
{\field\flddirty\fldpriv{\*\fld

								
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