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Fentex 447000FX

by FENTEX medical GmbH

Ref 447000FXModel Instrument zum Halten und Führen von Nadeln oder Nahtmaterial.

Fentex 447000FX is a Class I device made by FENTEX medical GmbH, registered in EUDAMED on 7 Sep 2026 (Basic UDI-DI B-04250407737610) and listed in FDA GUDID since 12 Dec 2022 (UDI-DI 04250407737610), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04250407737610 Basic UDI-DI 04250407737610UDI-DIDate7 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250407737610 UDI-DI Date12 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04250407737610 registered 7 Sep 2026 Active
  • FDA GUDID UDI-DI 04250407737610 listed 12 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250407737610
  2. Registered EUDAMED B-04250407737610

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Fentex
Generic name
Suturing unit, reusable
Model / Ref / Catalog
447000FX, Instrument zum Halten und Führen von Nadeln oder Nahtmaterial.
Description
Suture Hook round, pointed 20.5 cm
Primary DI / UDI-DI
04250407737610
Basic UDI-DI
B-04250407737610
FDA product code
LRC
EMDN code
L0299 Suture instruments, reusable - other
GMDN term
Suturing unit, reusable
Device class
Class I
Regulation number
874.4420
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Suturing needle, reusable

Similar devices in this category

Other devices filed under SUTURE INSTRUMENTS, REUSABLE - OTHER.

Other devices from FENTEX medical GmbH

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Properties

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