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Fentex 130100FX

by FENTEX medical GmbH

Ref 130100FXModel Instrument zur Kraftausübung.

Fentex 130100FX is a Class I device made by FENTEX medical GmbH, registered in EUDAMED on 7 Sep 2026 (Basic UDI-DI 42504077043K5) and listed in FDA GUDID since 8 Dec 2022 (UDI-DI 04250407713454), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42504077043K5 Basic UDI-DI 04250407713454UDI-DIDate7 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250407713454 UDI-DI Date8 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42504077043K5 registered 7 Sep 2026 Active
  • FDA GUDID UDI-DI 04250407713454 listed 8 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250407713454
  2. Registered EUDAMED 42504077043K5

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  • Withdrawn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
Fentex
Generic name
Surgical mallet
Model / Ref / Catalog
130100FX, Instrument zur Kraftausübung.
Description
Mallet by Hajek steel, solid 21 cm, 200 g
Primary DI / UDI-DI
04250407713454
Basic UDI-DI
42504077043K5
Direct marketing DI
04250407713454
FDA product code
MDM
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
Germany
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 FENTEX medical GmbH

See all devices from FENTEX medical GmbH →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)