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Acs® 42103605

by implantcast GmbH

Part of a family of 6 devices: see the family page

Ref 42103605Model KNB12SCFTCLINST

Acs® 42103605 is a device classified as Class IIa in the EU and Class I in the US made by implantcast GmbH, registered in EUDAMED on 21 Jul 2026 (Basic UDI-DI 4048844KNB12SCFTCLINSTNE) and listed in FDA GUDID since 25 Sep 2024 (UDI-DI 04048844137649), 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 Number4048844KNB12SCFTCLINSTNE Basic UDI-DI 04048844137649UDI-DIDate21 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048844137649 UDI-DI Date25 Sep 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048844KNB12SCFTCLINSTNE registered 21 Jul 2026 Active
  • FDA GUDID UDI-DI 04048844137649 listed 25 Sep 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048844137649
  2. Registered EUDAMED 4048844KNB12SCFTCLINSTNE

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  • Withdrawn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
Acs® Sc EUDAMED
Acs® GUDID
Generic name
Knee femur prosthesis trial, reusable
Model / reference
42103605, KNB12SCFTCLINST
Primary DI / UDI-DI
04048844137649
Basic UDI-DI
4048844KNB12SCFTCLINSTNE
FDA product code
HWT
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Knee femur prosthesis trial, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4800
EU registration type
Standard device
EU market of registration
Türkiye
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 IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Knee femur prosthesis trial, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from implantcast GmbH

See all devices from implantcast GmbH →

Properties

  • Sterilise before use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)