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Vitom TH002

by Karl Storz SE & CO. KG

Ref TH002

Vitom TH002 is a fixed examination/treatment room light (EU MDR Class I; FDA Class I; FDA product code EPT, Microscope, Surgical) made by Karl Storz SE & CO. KG, registered in EUDAMED on 28 May 2026 (Basic UDI-DI 4048551001570TZ) and listed in FDA GUDID since 21 Jul 2018 (UDI-DI 04048551387733), 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 Number4048551001570TZ Basic UDI-DI 04048551387733UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048551387733 UDI-DI Date21 Jul 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048551001570TZ registered 28 May 2026 Active
  • FDA GUDID UDI-DI 04048551387733 listed 21 Jul 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048551387733
  2. Registered EUDAMED 4048551001570TZ

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  • Withdrawn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
Fixed examination/treatment room light
Device name
Illuminators
Model / reference
TH002
Primary DI / UDI-DI
04048551387733
Basic UDI-DI
4048551001570TZ
FDA product code
EPT
EMDN code
Z12011199 Instruments for operative microscopy – other
GMDN term
Fixed examination/treatment room light
Device class
Class I
Regulation number
878.4700
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 04048551387733: EUDAMED states Yes, FDA GUDID states No.

Related devices

Category: Fixed examination/treatment room light

Similar devices in this category

Other devices filed under INSTRUMENTS FOR OPERATIVE MICROSCOPY – OTHER.

Other devices from Karl Storz SE & CO. KG

See all devices from Karl Storz SE & CO. KG →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)