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11540KA

by Karl Storz SE & CO. KG

Ref 11540KA

11540KA is a device classified as Class IIa (EU), Unclassified (US) made by Karl Storz SE & CO. KG, registered in EUDAMED on 19 May 2026 (Basic UDI-DI 4048551000225T6) and listed in FDA GUDID since 24 Sep 2014 (UDI-DI 04048551051399), 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 Number4048551000225T6 Basic UDI-DI 04048551051399UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048551051399 UDI-DI Date24 Sep 2014ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048551000225T6 registered 19 May 2026 Active
  • FDA GUDID UDI-DI 04048551051399 listed 24 Sep 2014 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048551051399
  2. Registered EUDAMED 4048551000225T6

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  • Withdrawn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
Endoscope sheath, reusable
Device name
Sheaths, irrigation, fetoscopy
Model / reference
11540KA
Primary DI / UDI-DI
04048551051399
Basic UDI-DI
4048551000225T6
FDA product code
HFA
EMDN code
L059099 Obstetrics and gynecology instruments, reusable - other
GMDN term
Endoscope sheath, reusable
Device class
Class IIa EUDAMED
Unclassified GUDID
Regulation number
884.1600
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
Unclassified

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

Related devices

Category: Endoscope sheath, reusable

Similar devices in this category

Other devices filed under OBSTETRICS AND GYNECOLOGY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Karl Storz SE & CO. KG

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Properties

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