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Acs® 42102316

by implantcast GmbH

Ref 42102316Model KNB15TISHINST

Acs® 42102316 is a Class I device made by implantcast GmbH, registered in EUDAMED on 7 Aug 2026 (Basic UDI-DI 4048844KNB15TISHINSTUW) and listed in FDA GUDID since 25 Sep 2024 (UDI-DI 04048844344030), 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 Number4048844KNB15TISHINSTUW Basic UDI-DI 04048844344030UDI-DIDate7 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048844344030 UDI-DI Date25 Sep 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048844KNB15TISHINSTUW registered 7 Aug 2026 Active
  • FDA GUDID UDI-DI 04048844344030 listed 25 Sep 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048844344030
  2. Registered EUDAMED 4048844KNB15TISHINSTUW

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  • Withdrawn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
Orthopaedic implant impactor, reusable
Model / reference
42102316, KNB15TISHINST
Primary DI / UDI-DI
04048844344030
Basic UDI-DI
4048844KNB15TISHINSTUW
Direct marketing DI
04048844344030
FDA product code
HWA
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic implant impactor, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic implant impactor, 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
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)