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OPMI Lumera 700 6634

by Carl Zeiss Meditec AG

Ref 6634Model OPMI Lumera 700 floor stand, OPMI Lumera 700 ceiling mount, ARTEVO 800

OPMI Lumera 700 6634 is an ophthalmic surgical microscope (EU MDR Class I; FDA Class I; FDA product code HRM, Microscope, Operating & Accessories, Ac-Powered, Ophthalmic) made by Carl Zeiss Meditec AG, registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 4049539_0_6217_T8) and listed in FDA GUDID since 23 Mar 2023 (UDI-DI 04049539066343), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4049539_0_6217_T8 Basic UDI-DI 04049539066343UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049539066343 UDI-DI Date23 Mar 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4049539_0_6217_T8 registered 23 Jul 2026 Active
  • FDA GUDID UDI-DI 04049539066343 listed 23 Mar 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04049539066343
  2. Registered EUDAMED 4049539_0_6217_T8

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  • Withdrawn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
OPMI Lumera 700 (floor stand) EUDAMED
OPMI Lumera 700 GUDID
Generic name
Ophthalmic surgical microscope
Device name
Surgical Microscope
Model / reference
6634, OPMI Lumera 700 floor stand, OPMI Lumera 700 ceiling mount, ARTEVO 800
Primary DI / UDI-DI
04049539066343
Basic UDI-DI
4049539_0_6217_T8
Direct marketing DI
04049539066343
FDA product code
HRM
EMDN code
Z12011101 Operative microscopes
GMDN term
Ophthalmic surgical microscope
Device class
Class I
Regulation number
878.4700
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ophthalmic surgical microscope

Similar devices in this category

Other devices filed under OPERATIVE MICROSCOPES.

Other devices from Carl Zeiss Meditec AG

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Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)