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Fentex 100313FX

by FENTEX medical GmbH

Ref 100313FXModel Spreizer und Retraktoren dienen zum Offenhalten des Operationsfelds. Dies bedeutet Abhalten von Gewebe, Muskeln, Organe.

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

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 Number04250407708764 UDI-DI Date7 Dec 2022ListedStatusListed GUDID: in commercial distribution

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

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  • Withdrawn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 retraction system, reusable
Model / Ref / Catalog
100313FX, Spreizer und Retraktoren dienen zum Offenhalten des Operationsfelds. Dies bedeutet Abhalten von Gewebe, Muskeln, Organe.
Description
Retractor by Weitlaner sharp 13 cm, 3 x 4 prongs
Primary DI / UDI-DI
04250407708764
Basic UDI-DI
42504077300K2
Direct Marketing DI
04250407708764
FDA Product Code
KAL
EMDN Code
L03140199 Spreaders and retractors for general surgery, reusable - other
GMDN Term
Surgical retraction system, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
874.4420
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Self-retaining surgical retractor, 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