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Fentex 530111FX

by FENTEX medical GmbH

Part of a family of 26 devices: see the family page

Ref 530111FXModel Instrumente zur Erweiterung und Darstellung verschiedener Larynx-Anatomien zur Unterstützung chirurgischer Eingriffe.

Fentex 530111FX is a Class I device made by FENTEX medical GmbH, registered in EUDAMED on 7 Sep 2026 (Basic UDI-DI 42504077302K6) and listed in FDA GUDID since 12 Dec 2022 (UDI-DI 04250407740863), 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 Number42504077302K6 Basic UDI-DI 04250407740863UDI-DIDate7 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250407740863 UDI-DI Date12 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42504077302K6 registered 7 Sep 2026 Active
  • FDA GUDID UDI-DI 04250407740863 listed 12 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250407740863
  2. Registered EUDAMED 42504077302K6

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  • Withdrawn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 transilluminator
Model / Ref / Catalog
530111FX, Instrumente zur Erweiterung und Darstellung verschiedener Larynx-Anatomien zur Unterstützung chirurgischer Eingriffe.
Description
Fiber Optic Light Carrier for 530106FX-107FX + 530206FX-207FX 13 cm, Ø 3.5 mm
Primary DI / UDI-DI
04250407740863
Basic UDI-DI
42504077302K6
Direct marketing DI
04250407740863
FDA product code
CCW
EMDN code
Z12021003 Laryngoscopes
GMDN term
ENT transilluminator
Device class
Class I
Regulation number
868.5540
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: ENT transilluminator

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Properties

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