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OPMI Lumera i 6633

by Carl Zeiss Meditec AG

Ref 6633Model OPMI Lumera i

OPMI Lumera i 6633 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_6216_T5) and listed in FDA GUDID since 31 Mar 2023 (UDI-DI 04049539066336), 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_6216_T5 Basic UDI-DI 04049539066336UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049539066336 UDI-DI Date31 Mar 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4049539_0_6216_T5 registered 23 Jul 2026 Active
  • FDA GUDID UDI-DI 04049539066336 listed 31 Mar 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04049539066336
  2. Registered EUDAMED 4049539_0_6216_T5

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  • Withdrawn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 i
Generic name
Ophthalmic surgical microscope
Device name
Surgical Microscopes
Model / reference
6633, OPMI Lumera i
Primary DI / UDI-DI
04049539066336
Basic UDI-DI
4049539_0_6216_T5
Direct marketing DI
04049539066336
FDA product code
HRM
EMDN code
Z12101101 Somatosensory evoked potential analysers
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 PERIPHERAL OR CENTRAL NEURO STIMULATION AND ASSESSMENT INSTRUMENTS.

Other devices from Carl Zeiss Meditec AG

See all devices from Carl Zeiss Meditec AG →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)