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Focusing Module BIOM 6, 175 mm 10035110

by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Ref 10035110

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number404958454Q8 Basic UDI-DI 04049584037695UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049584037695 UDI-DI Date23 Jan 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Focusing Module BIOM® 6, 175mm EUDAMED
Focusing Module BIOM 6, 175 mm GUDID
Generic Name
Ophthalmic surgical microscope
Device Name
BIOM 6 Focusing Modul
Model / Reference
10035110
Primary DI / UDI-DI
04049584037695
Basic UDI-DI
404958454Q8
FDA Product Code
HRM
EMDN Code
Z12129099 Various ophtalmology instruments - other
GMDN Term
Ophthalmic surgical microscope
Device Class
Class I
Regulation Number
878.4700
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

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Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No