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TL005

by Karl Storz SE & CO. KG

Ref TL005

TL005 is a device classified as Class I in the EU and Class II in the US made by Karl Storz SE & CO. KG, registered in EUDAMED on 19 May 2026 (Basic UDI-DI 4048551001748UJ) and listed in FDA GUDID since 21 Jul 2018 (UDI-DI 04048551392508), 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 Number4048551001748UJ Basic UDI-DI 04048551392508UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048551392508 UDI-DI Date21 Jul 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048551001748UJ registered 19 May 2026 Active
  • FDA GUDID UDI-DI 04048551392508 listed 21 Jul 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048551392508
  2. Registered EUDAMED 4048551001748UJ

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  • Withdrawn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
Endoscopic light source unit, line-powered
Device name
Adaptors, light sources/light cables, metal, plastics
Model / reference
TL005
Primary DI / UDI-DI
04048551392508
Basic UDI-DI
4048551001748UJ
FDA product code
FCW
EMDN code
Z12020480 Instruments for the acquisition and management of endoscopic and minimally invasive surgery images - hardware accessories
GMDN term
Endoscopic light source unit, line-powered
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: Endoscopic light source unit, line-powered

Similar devices in this category

Other devices filed under INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES - HARDWARE ACCESSORIES.

Other devices from Karl Storz SE & CO. KG

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Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)