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42006100

by implantcast GmbH

Ref 42006100Model KNB14AFFINST

42006100 is a Class I device made by implantcast GmbH, registered in EUDAMED on 3 Jul 2026 (Basic UDI-DI 4048844KNB14AFFINSTH8) and listed in FDA GUDID since 25 Sep 2024 (UDI-DI 04048844390884), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4048844KNB14AFFINSTH8 Basic UDI-DI 04048844390884UDI-DIDate3 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048844390884 UDI-DI Date25 Sep 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048844KNB14AFFINSTH8 registered 3 Jul 2026 Active
  • FDA GUDID UDI-DI 04048844390884 listed 25 Sep 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048844390884
  2. Registered EUDAMED 4048844KNB14AFFINSTH8

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  • Withdrawn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
Orthopaedic implant-instrument extension adaptor, reusable
Model / reference
42006100, KNB14AFFINST
Primary DI / UDI-DI
04048844390884
Basic UDI-DI
4048844KNB14AFFINSTH8
Direct marketing DI
04048844390884
FDA product code
LXH
EMDN code
L0317 General surgery adapters and connectors, reusable
GMDN term
Orthopaedic implant-instrument extension adaptor, 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: Orthopaedic implant-instrument extension adaptor, reusable

Similar devices in this category

Other devices filed under GENERAL SURGERY ADAPTERS AND CONNECTORS, REUSABLE.

Other devices from implantcast GmbH

See all devices from implantcast GmbH →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)