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091279-01

by Karl Storz SE & CO. KG

Ref 091279-01

091279-01 is a device classified as Class IIa 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 4048551000063T4) and listed in FDA GUDID since 4 Oct 2024 (UDI-DI 04048551428023), 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 Number4048551000063T4 Basic UDI-DI 04048551428023UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048551428023 UDI-DI Date4 Oct 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048551000063T4 registered 19 May 2026 Active
  • FDA GUDID UDI-DI 04048551428023 listed 4 Oct 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048551428023
  2. Registered EUDAMED 4048551000063T4

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  • Withdrawn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
Flexible video ureterorenoscope, single-use
Device name
Flexible videoendoscopes, sterile, single use
Model / Ref / Catalog
091279-01
Primary DI / UDI-DI
04048551428023
Basic UDI-DI
4048551000063T4
FDA product code
FGB
EMDN code
Z12020711 Video cystourethroscopes
GMDN term
Flexible video ureterorenoscope, single-use
Device class
Class IIa 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 IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Flexible video ureterorenoscope, single-use

Similar devices in this category

Other devices filed under VIDEO CYSTOURETHROSCOPES.

Other devices from Karl Storz SE & CO. KG

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)