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28163FKD

by Karl Storz SE & CO. KG

Ref 28163FKD

28163FKD 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 4048551001718U9) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04048551309452), 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 Number4048551001718U9 Basic UDI-DI 04048551309452UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048551309452 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048551001718U9 registered 19 May 2026 Active
  • FDA GUDID UDI-DI 04048551309452 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048551309452
  2. Registered EUDAMED 4048551001718U9

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  • Withdrawn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
Surgical instrument handle, non-torque-limiting
Device name
Fixation handles
Model / reference
28163FKD
Primary DI / UDI-DI
04048551309452
Basic UDI-DI
4048551001718U9
FDA product code
HRX
EMDN code
L11050199 Vertebral surgery spreaders and retractors, reusable - other
GMDN term
Surgical instrument handle, non-torque-limiting
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.1100
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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: Surgical instrument handle, non-torque-limiting

Similar devices in this category

Other devices filed under VERTEBRAL SURGERY SPREADERS AND RETRACTORS, REUSABLE - OTHER.

Other devices from Karl Storz SE & CO. KG

See all devices from Karl Storz SE & CO. KG →

Properties

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