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Fentex 116313FX

by FENTEX medical GmbH

Ref 116313FXModel Instrument zum Schaffen eines Sichtfelds.

Fentex 116313FX is a Class I device made by FENTEX medical GmbH, registered in EUDAMED on 7 Sep 2026 (Basic UDI-DI 42504077028K9) and listed in FDA GUDID since 7 Dec 2022 (UDI-DI 04250407712099), 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 Number42504077028K9 Basic UDI-DI 04250407712099UDI-DIDate7 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250407712099 UDI-DI Date7 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42504077028K9 registered 7 Sep 2026 Active
  • FDA GUDID UDI-DI 04250407712099 listed 7 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250407712099
  2. Registered EUDAMED 42504077028K9

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  • Withdrawn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
Ear speculum, reusable
Model / Ref / Catalog
116313FX, Instrument zum Schaffen eines Sichtfelds.
Description
Ear Speculum by Farrior oval, 20° oblique, black finish size 3
Primary DI / UDI-DI
04250407712099
Basic UDI-DI
42504077028K9
Direct marketing DI
04250407712099
FDA product code
EPY
EMDN code
L149004 ENT speculums, reusable
GMDN term
Ear speculum, reusable
Device class
Class I
Regulation number
878.1800
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 speculum, reusable

Similar devices in this category

Other devices filed under ENT INSTRUMENTS, REUSABLE - VARIOUS.

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)