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Fentex 167108FX

by FENTEX medical GmbH

Ref 167108FXModel Instrument zum Anschluss an ein Saug- / Spülgerät zur Absaugung von Flüssigkeiten und zur Spülung des Operationsfeldes.

Fentex 167108FX is a device classified as Class IIa in the EU and Class I in the US made by FENTEX medical GmbH, registered in EUDAMED on 7 Sep 2026 (Basic UDI-DI 42504077200JV) with CE/MDR certificate 1000265375 valid until 11 Oct 2031 and listed in FDA GUDID since 8 Dec 2022 (UDI-DI 04250407717902), active as of 23 Oct 2026.

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

CE MDR

Valid until

11 Oct 2031

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1000265375 Date12 Oct 2026IssuedStatusActive expires 11 Oct 2031
United StatesGUDID listing GUDID Number04250407717902 UDI-DI Date8 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42504077200JV registered 7 Sep 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04250407717902 listed 8 Dec 2022 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000265375 Active

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    12 Oct 2026
    Expires
    11 Oct 2031

Timeline

4 dated events

  1. Listed FDA GUDID 04250407717902
  2. Registered EUDAMED 42504077200JV
  3. Certificate issued EUDAMED 1000265375
  4. Certificate expires EUDAMED 1000265375

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  • Withdrawn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
Surgical/emergency suction cannula, non-illuminating, reusable
Model / Ref / Catalog
167108FX, Instrument zum Anschluss an ein Saug- / Spülgerät zur Absaugung von Flüssigkeiten und zur Spülung des Operationsfeldes.
Description
Suction Tube by Plester with cut-off hole, Luer 19 cm, 8 Fr.
Primary DI / UDI-DI
04250407717902
Basic UDI-DI
42504077200JV
Direct marketing DI
04250407717902
FDA product code
LRC
EMDN code
L030101 Suction and irrigation surgical cannulas and handpieces, reusable
GMDN term
Surgical/emergency suction cannula, non-illuminating, reusable
Device class
Class IIa EUDAMED
Class I GUDID
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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Surgical irrigation/aspiration cannula, non-illuminating, reusable

Similar devices in this category

Other devices filed under SUCTION AND IRRIGATION SURGICAL CANNULAS AND HANDPIECES, REUSABLE.

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)