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TH201

by Karl Storz SE & CO. KG

Ref TH201

TH201 is a video camera surgical microscope system (EU MDR Class I; FDA Class II; FDA product code OWN, Confocal optical imaging) made by Karl Storz SE & CO. KG, registered in EUDAMED on 19 May 2026 (Basic UDI-DI 4048551005091UC) and listed in FDA GUDID since 27 Mar 2025 (UDI-DI 04048551418871), 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 Number4048551005091UC Basic UDI-DI 04048551418871UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048551418871 UDI-DI Date27 Mar 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048551005091UC registered 19 May 2026 Active
  • FDA GUDID UDI-DI 04048551418871 listed 27 Mar 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048551418871
  2. Registered EUDAMED 4048551005091UC

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  • Withdrawn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

Generic name
Video camera surgical microscope system
Device name
3D exoscopes, NIR/ICG, 5-ALA, Fluorescein function
Model / Ref / Catalog
TH201
Primary DI / UDI-DI
04048551418871
Basic UDI-DI
4048551005091UC
FDA product code
OWN
EMDN code
Z12011101 Operative microscopes
GMDN term
Video camera surgical microscope system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
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
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Video camera surgical microscope system

Similar devices in this category

Other devices filed under OPERATIVE MICROSCOPES.

Other devices from Karl Storz SE & CO. KG

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

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)