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65000012

by implantcast GmbH

Ref 65000012Model UMUT24SHSMINST

65000012 is a Class I device made by implantcast GmbH, registered in EUDAMED on 28 Aug 2026 (Basic UDI-DI 4048844UMUT24SHSMINSTCF) and listed in FDA GUDID since 30 Nov 2023 (UDI-DI 04048844052478), 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 Number4048844UMUT24SHSMINSTCF Basic UDI-DI 04048844052478UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048844052478 UDI-DI Date30 Nov 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048844UMUT24SHSMINSTCF registered 28 Aug 2026 Active
  • FDA GUDID UDI-DI 04048844052478 listed 30 Nov 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048844052478
  2. Registered EUDAMED 4048844UMUT24SHSMINSTCF

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  • Withdrawn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
Surgical mallet
Model / reference
65000012, UMUT24SHSMINST
Primary DI / UDI-DI
04048844052478
Basic UDI-DI
4048844UMUT24SHSMINSTCF
Direct marketing DI
04048844052478
FDA product code
FZY
EMDN code
L0903 Orthopaedic surgery hammers, reusable
GMDN term
Surgical mallet
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical mallet

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY HAMMERS, 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)