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Fentex 239502FX

by FENTEX medical GmbH

Ref 239502FXModel Instrument zum Schneiden.

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 24 Oct 2026.

Overview

FENTEX is a high-grade stainless steel hand-held manual surgical instrument designed for ear, nose, and throat (ENT) surgery. This one-piece instrument features a unique cutting blade made of various forms, including sharply-pointed, double-edged, or swivel devices, tailored to specific procedures. With its sterilization methods available as Moist Heat or Steam Sterilization, FENTEX ensures effective infection control during surgical operations.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04250407725273 Basic UDI-DI 04250407725273UDI-DIDate7 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250407725273 UDI-DI Date9 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04250407725273 registered 7 Sep 2026 Active
  • FDA GUDID UDI-DI 04250407725273 listed 9 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250407725273
  2. Registered EUDAMED B-04250407725273

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  • Withdrawn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
Ear knife
Model / Ref / Catalog
239502FX, Instrument zum Schneiden.
Description
Round Knife by Draf bayonet-shaped, vertical cutting 19 cm
Primary DI / UDI-DI
04250407725273
Basic UDI-DI
B-04250407725273
FDA product code
LRC
EMDN code
L140503 Ear surgery scalpels and knives, reusable
GMDN term
Ear knife
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: Nasal knife

Similar devices in this category

Other devices filed under EAR SURGERY INSTRUMENTS, REUSABLE.

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)