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Duratwix 19601-10

by Andreas Fahl Medizintechnik-Vertrieb GmbH EUDAMEDGUDID

Withdrawn European Union and United States

Ref 19601-10

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number405194819201DURATWIX+PP5U Basic UDI-DIDate21 Sep 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number04051948033243 UDI-DIDate28 Oct 2016ListedStatusWithdrawn

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Withdrawn
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Duratwix® Uni Cuff, SIZE 10 EUDAMED
Duratwix GUDID
Generic Name
Tracheostomy tube, non-reinforced, non-customized, reusable
Device Name
Duratwix PP
Model / Reference
19601-10
Primary DI / UDI-DI
04051948033243
Basic UDI-DI
405194819201DURATWIX+PP5U
FDA Product Code
BTR, BTO, JOH
EMDN Code
R0105020101 Tracheostomic cannulas, cuffed, not reinforced, with fixed flange, and kits
GMDN Term
Tracheostomy tube, non-reinforced, non-customized, reusable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
868.5730, 868.5800
Medical Purpose
FAHL® tracheostomy tubes are intended to stabilise the tracheostomy following laryngectomy or tracheotomy. The tracheostomy tube is designed to keep the tracheostomy open. Tracheostomy tubes with cuff can be used for mechanical ventilation, including under anaesthesia. Percutan variants are designed for additional use in percutaneous dilatation tracheostomy.
Commercial Distribution
Not in Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Other devices from Andreas Fahl Medizintechnik-Vertrieb GmbH

See all devices from Andreas Fahl Medizintechnik-Vertrieb GmbH →

Properties

  • Sterile
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No