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Acs® 42140612

by implantcast GmbH

Ref 42140612Model KNB12FBTPEIINST

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4048844KNB12FBTPEIINSTFV Basic UDI-DI 04048844116323UDI-DIDate21 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048844116323 UDI-DI Date25 Sep 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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® Fb EUDAMED
Acs® GUDID
Generic name
Knee tibia prosthesis trial, reusable
Model / reference
42140612, KNB12FBTPEIINST
Primary DI / UDI-DI
04048844116323
Basic UDI-DI
4048844KNB12FBTPEIINSTFV
Direct marketing DI
04048844116323
FDA product code
HWT
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Knee tibia prosthesis trial, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4800
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 IIa
GUDID
Class I

Related devices

Category: Knee tibia prosthesis trial, reusable

Other devices from implantcast GmbH

See all devices from implantcast GmbH →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number

Other properties (22)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No