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42234003

by implantcast GmbH

Ref 42234003Model UKNB15MKSABINST

42234003 is a Class I device made by implantcast GmbH, registered in EUDAMED on 7 Aug 2026 (Basic UDI-DI 4048844UKNB15MKSABINSTD6) and listed in FDA GUDID since 30 Sep 2024 (UDI-DI 04048844238728), 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 Number4048844UKNB15MKSABINSTD6 Basic UDI-DI 04048844238728UDI-DIDate7 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048844238728 UDI-DI Date30 Sep 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048844UKNB15MKSABINSTD6 registered 7 Aug 2026 Active
  • FDA GUDID UDI-DI 04048844238728 listed 30 Sep 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048844238728
  2. Registered EUDAMED 4048844UKNB15MKSABINSTD6

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  • Withdrawn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

Trade name
Mk
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / reference
42234003, UKNB15MKSABINST
Primary DI / UDI-DI
04048844238728
Basic UDI-DI
4048844UKNB15MKSABINSTD6
Direct marketing DI
04048844238728
FDA product code
LXH
EMDN code
L0922 Orthopaedic surgery guides, reusable
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY GUIDES, REUSABLE.

Other devices from implantcast GmbH

See all devices from implantcast GmbH →

Properties

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