Declaration of Conformity - DOC by 0Xds8Yhy

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									                       Magitech Implant Innovation.

       Medical Device Directive 93/42/EEC & MDD 2007/47
           EC DECLARATION OF CONFORMITY

Manufacturer:                Magitech Implant Innovation
                             140 av victor hugo 75016 Paris
                                                                                             0473
Products:              Dental Implants and accessories
Placed the products in the European market, declare that our products conform and meet the
essential requirements set out in Annex I of the Medical Device Directive 93/42 EEC.


Appointed Notified Body: AMTAC Certification Services Limited (Intertek) (NB # 0473) for
the requirements of MDD 93/42/EEC Annex II.


Product:                                           Model:                       Class
Dental Implants                                    See List Attached             IIb
Recovery Accessories                               See List Attached             IIa


Conforming to Production Standards:
     ISO 9001:2008 / ISO 13485:2003
     MDD 93/42EEC & MDD 2007/47
      Statutory Instrument SI2008, No. 2936


Full Name: _______________                                  Position: ________________

Date: ________________                                      Signature: ___________________
Rev: 2.0




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                Magitech Implant Innovation.


Catalog #              Description
IMP-A-XXXXXX           SHARK IMPLANTS TITANIUM
IMP-TO-XXXXXX          TORNADO IMPLANTS TITANIUM
IMP-D-XXXXXX           CYLINDER IMPLANTS TITANIUM
IMP-O-XXXXXX           IMPLANTS ONE PIECE TITANIUM
IMP-INS-01             S.S. 303 MOUNT INSERTION
IMP-INS-02             TITANIUM SCREW CAP
ABT-S                  57.3(    TITANIUM ABUTMENT STRAIGHT(
ABT-W                  77.(    STRAIGHT TITANIUM ABUTMENT(
ABT-L                  LONG(       STRAIGHT TITANIUM ABUTMENT(
ABS-1                  m"m SHOULDER 1(       TITANIUM ABUTMENT STRAIGHT(
ABS-2                  m"SHOULDER 2 m(       STRAIGHT TITANIUM ABUTMENT(
ABS-3                  m"SHOULDER 3 m(       STRAIGHT TITANIUM ABUTMENT(
ABS-4                  m"SHOULDER 4 m(       STRAIGHT TITANIUM ABUTMENT(
                       O
ABT-A15                 53(     TITANIUM ABUTMENT Angulated(
                       O
ABT-A25                 53(     Angulated TITANIUM ABUTMENT(
BAT-1                  m"h 1 m (     BALL ATTACHMENT TITANIUM(
BAT-2                  m"h 2 m (     TITANIUM BALL ATTACHMENT(
BAT-3                  m"h 3 m (     TITANIUM BALL ATTACHMENT(
BAT-4                  m"h 4 m (     TITANIUM BALL ATTACHMENT(
BAT-5                  m"h 5 m (     TITANIUM BALL ATTACHMENT(
HEC-2                  m"h 2 m (     CAP TITANIUMHEALING(
HEC-3                  m"h 3 m (     CAP TITANIUMHEALING(
HEC-4                  m"h 4 m (     TITANIUMHEALING CAP(
HEC-5                  m"h 5 m (     TITANIUMHEALING CAP(
HEC-6                  m"h 6 m (     TITANIUMHEALING CAP(
ANL-S                  ANALOG-STANDARD
TRN-L                  TRANSFER-STANDARD
TRN-S                  TRANSFER-SHORT




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