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TL400

by Karl Storz SE & CO. KG

Ref TL400

TL400 is a device classified as Class IIa in the EU and Class III in the US made by Karl Storz SE & CO. KG, registered in EUDAMED on 19 May 2026 (Basic UDI-DI 4048551000523TH) and listed in FDA GUDID since 20 Dec 2024 (UDI-DI 04048551425695), 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 Number4048551000523TH Basic UDI-DI 04048551425695UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048551425695 UDI-DI Date20 Dec 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048551000523TH registered 19 May 2026 Active
  • FDA GUDID UDI-DI 04048551425695 listed 20 Dec 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048551425695
  2. Registered EUDAMED 4048551000523TH

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  • Withdrawn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
NIR Fluorescence light sources
Model / Ref / Catalog
TL400
Primary DI / UDI-DI
04048551425695
Basic UDI-DI
4048551000523TH
FDA product code
MNO, GWG, FET
EMDN code
Z12020402 Light sources for endoscopy and minimally invasive surgery
GMDN term
Endoscopic light source unit, line-powered
Device class
Class IIa EUDAMED
Class III GUDID
Regulation number
882.1480, 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 IIa
GUDID
Class III

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class III 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 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY.

Other devices from Karl Storz SE & CO. KG

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Properties

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