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42210277

by implantcast GmbH

Ref 42210277Model UKNB14TCBA

42210277 is a device classified as Class I in the EU and Class II in the US made by implantcast GmbH, registered in EUDAMED on 3 Jul 2026 (Basic UDI-DI 4048844UKNB14TCBAUS) and listed in FDA GUDID since 27 Sep 2024 (UDI-DI 04048844501945), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4048844UKNB14TCBAUS Basic UDI-DI 04048844501945UDI-DIDate3 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048844501945 UDI-DI Date27 Sep 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048844UKNB14TCBAUS registered 3 Jul 2026 Active
  • FDA GUDID UDI-DI 04048844501945 listed 27 Sep 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048844501945
  2. Registered EUDAMED 4048844UKNB14TCBAUS

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  • Withdrawn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 fixation implant alignment tool
Model / reference
42210277, UKNB14TCBA
Primary DI / UDI-DI
04048844501945
Basic UDI-DI
4048844UKNB14TCBAUS
FDA product code
JWH
EMDN code
L0317 General surgery adapters and connectors, reusable
GMDN term
Orthopaedic fixation implant alignment tool
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3560
EU registration type
Standard device
EU market of registration
Spain
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: Orthopaedic fixation implant alignment tool

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)
  • Lot / batch number
Other properties (21, all answered No)