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Vitom 20916025AA

by Karl Storz SE & CO. KG

Ref 20916025AA

Vitom 20916025AA is a Class I device made by Karl Storz SE & CO. KG, registered in EUDAMED on 19 May 2026 (Basic UDI-DI 4048551000381TM) and listed in FDA GUDID since 23 Feb 2019 (UDI-DI 04048551324745), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4048551000381TM Basic UDI-DI 04048551324745UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048551324745 UDI-DI Date23 Feb 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048551000381TM registered 19 May 2026 Active
  • FDA GUDID UDI-DI 04048551324745 listed 23 Feb 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048551324745
  2. Registered EUDAMED 4048551000381TM

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  • Withdrawn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
Vitom
Generic name
Surgical microscope video camera, sterilizable
Device name
2D exoscopes
Model / reference
20916025AA
Primary DI / UDI-DI
04048551324745
Basic UDI-DI
4048551000381TM
FDA product code
EPT
EMDN code
Z12011101 Operative microscopes
GMDN term
Surgical microscope video camera, sterilizable
Device class
Class I
Regulation number
878.4700
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical microscope video camera, sterilizable

Similar devices in this category

Other devices filed under OPERATIVE MICROSCOPES.

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Properties

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