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Fentex 833154FX

by FENTEX medical GmbH

Part of a family of 9 devices: see the family page

Ref 833154FXModel Medizinprodukt zur manuellen Erzeugung eines Luftstroms.

Fentex 833154FX is an ENT powder applicator (EU MDR Class I; FDA Class I; FDA product code LRC, Instrument, Ent Manual Surgical) made by FENTEX medical GmbH, registered in EUDAMED on 7 Sep 2026 (Basic UDI-DI 42504077047KD) and listed in FDA GUDID since 12 Dec 2022 (UDI-DI 04250407754648), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42504077047KD Basic UDI-DI 04250407754648UDI-DIDate7 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250407754648 UDI-DI Date12 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42504077047KD registered 7 Sep 2026 Active
  • FDA GUDID UDI-DI 04250407754648 listed 12 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250407754648
  2. Registered EUDAMED 42504077047KD

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  • Withdrawn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
ENT powder applicator
Model / Ref / Catalog
833154FX, Medizinprodukt zur manuellen Erzeugung eines Luftstroms.
Description
Ear Tip for 824100FX Ø 4 mm
Primary DI / UDI-DI
04250407754648
Basic UDI-DI
42504077047KD
Direct marketing DI
04250407754648
FDA product code
LRC
EMDN code
Q030199 Nasopharyngeal devices - other
GMDN term
ENT powder applicator
Device class
Class I
Regulation number
874.4420
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: Ear canal irrigation tip

Similar devices in this category

Other devices filed under NASOPHARYNGEAL DEVICES - OTHER.

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)