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SDI 4m mechanically 54302

by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Ref 54302

SDI 4m mechanically 54302 is an ophthalmic surgical microscope (EU MDR Class I; FDA Class I; FDA product code HRM, Microscope, Operating & Accessories, Ac-Powered, Ophthalmic) made by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI 40495849BS) and listed in FDA GUDID since 2 Dec 2022 (UDI-DI 04049584008046), 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 Number40495849BS Basic UDI-DI 04049584008046UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049584008046 UDI-DI Date2 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40495849BS registered 7 Oct 2026 Active
  • FDA GUDID UDI-DI 04049584008046 listed 2 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04049584008046
  2. Registered EUDAMED 40495849BS

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  • Withdrawn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
SDI® 4m mechanisch EUDAMED
SDI 4m mechanically GUDID
Generic name
Ophthalmic surgical microscope
Device name
Sdi 4
Model / reference
54302
Primary DI / UDI-DI
04049584008046
Basic UDI-DI
40495849BS
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 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 VARIOUS OPHTALMOLOGY INSTRUMENTS - OTHER.

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Properties

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