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IMAGE1 Pilot TC014

by Karl Storz SE & CO. KG

Ref TC014

IMAGE1 Pilot TC014 is a desktop computer (EU MDR Class I; FDA Class I; FDA product code EPT, Microscope, Surgical) made by Karl Storz SE & CO. KG, registered in EUDAMED on 19 May 2026 (Basic UDI-DI 4048551001564U6) and listed in FDA GUDID since 2 Mar 2020 (UDI-DI 04048551387337), 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 Number4048551001564U6 Basic UDI-DI 04048551387337UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048551387337 UDI-DI Date2 Mar 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048551001564U6 registered 19 May 2026 Active
  • FDA GUDID UDI-DI 04048551387337 listed 2 Mar 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048551387337
  2. Registered EUDAMED 4048551001564U6

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  • Withdrawn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
IMAGE1 Pilot
Generic name
Desktop computer
Device name
Input devices
Model / reference
TC014
Primary DI / UDI-DI
04048551387337
Basic UDI-DI
4048551001564U6
FDA product code
EPT
EMDN code
Z12020406 Video processors
GMDN term
Desktop computer
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: Desktop computer

Similar devices in this category

Other devices filed under VIDEO PROCESSORS.

Other devices from Karl Storz SE & CO. KG

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Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)