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Fentex 116103FX

by FENTEX medical GmbH

Ref 116103FXModel Instrument zum Schaffen eines Sichtfelds.

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42504077028K9 Basic UDI-DI 04250407711726UDI-DIDate7 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250407711726 UDI-DI Date7 Dec 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
116103FX, Instrument zum Schaffen eines Sichtfelds.
Description
Ear Speculum by Farrior round, straight size 3
Primary DI / UDI-DI
04250407711726
Basic UDI-DI
42504077028K9
Direct Marketing DI
04250407711726
FDA Product Code
EPY
EMDN Code
L149004 ENT speculums, reusable
GMDN Term
Ear speculum, reusable
Device Class
Class I
Regulation Number
878.1800
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Ear speculum, reusable

Other devices from FENTEX medical GmbH

See all devices from FENTEX medical GmbH →

Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No