InterCert
aS Certificate
Directive to GmbH- notified body no.1275according the Council The LGA lnterCert - herewith following company that confirms the devices medical concerning
oculentis
GmbH oculentis 58 Am Borsigturm Berlin 13507 Germany
a applies
qualityassurance system
of for the manufacture the class I medicaldeviceslisted in the enclosureaccordingto the
AnnexV Directive93/42|EEC,
steps in connectionwith sterilization restrictedto the manufacturing of and maintenance sterilitY forthescopes: sets. sets surgery anddraping sterile 4 V, to as to is Thesystem subject surveillance referred in Annex Section ll, 5. to is according annex section GmbH effected through LGAInterCert the Thesurveillance
is This certificate valid untilOctober29,2010 no. 868-14b-000-001 Registration : 1871 no.: 1871868 Auditreport of: October19,2007
to for It is allowed the company sign the products with the in specified the enclosure sign. adjoining
(*) first issue Novembe(4,2OO7 Reg. no.: 1871868-14b{00 (changedthe @mpany name) ,
' Nürnberg Tel.+499 11 6 55-5780 2 GmbH' Tillystr. ' D-90431 LGAInterCert
InterCerJ
of no. Registration 1871868-14b-000 the company Enclosureof the Gertificate 58, oculentisGmbH,Am Borrsigturm 13507Berlin,Germany
29,2010 Dateof expiryOctober medical devices: refersto following certificate The above-mentioned No.
1.
Product Gasework list to typesaccording reference Covers, Surgical,Disposable Drapes, list to Typesaccording reference Drains,Wound list to Typesaccording reference Ophthalmic Sponges, list to Typesaccording reference Gowns, OperatingRoom,Disposable list to Typesaccording reference Eye Gannulae, list to Typesaccording reference Collectionbags 30 x 25 cm Collection bags 25 x 25 cm Gollection bags 15x 15 cm InciseDrapes10x 15cm 12x 100mm Strip sterile1547R,
UMDNSNo.
Class ls ls ls ls ls ls ls ls ls ls ls
15-895 15-646 11- 305 13-704 11-901 10-573
*
2.
3.
4.
5.
6.
7. 8. 9. 10.
11.
* * *
*At present UMDNS is number available. no
name)of March4, 2008 the Modification (changed company 4b-000-001 (Procedure-No. No. 868-1 Registration : 1871 : 1880834; ))
' Ntirnberg Tel.+499 11 6 55-5780 2 LGAlntercertGmbH' Tillystr. ' D-90431