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28163FEH

by Karl Storz SE & CO. KG

Ref 28163FEH

28163FEH is a Class I device made by Karl Storz SE & CO. KG, registered in EUDAMED on 19 May 2026 (Basic UDI-DI 4048551000908U9) and listed in FDA GUDID since 4 Sep 2018 (UDI-DI 04048551100295), 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 Number4048551000908U9 Basic UDI-DI 04048551100295UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048551100295 UDI-DI Date4 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048551000908U9 registered 19 May 2026 Active
  • FDA GUDID UDI-DI 04048551100295 listed 4 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048551100295
  2. Registered EUDAMED 4048551000908U9

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  • Withdrawn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
Impact sleeves
Model / reference
28163FEH
Primary DI / UDI-DI
04048551100295
Basic UDI-DI
4048551000908U9
FDA product code
LXH
EMDN code
L11050199 Vertebral surgery spreaders and retractors, reusable - other
GMDN term
Endoscope sheath, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Endoscope sheath, reusable

Similar devices in this category

Other devices filed under NEUROSURGERY AND SPINAL SURGERY INSTRUMENTS, REUSABLE.

Other devices from Karl Storz SE & CO. KG

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)