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Rota-Trach Disposable Standard Tracheostomy Tube

by Vitaltec Corporation EUDAMED

Active European Union

Ref 5310800

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04711467491176 Basic UDI-DIDate4 Oct 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Tracheostomy tubes, with cuff
Model / Reference
5310800
Primary DI / UDI-DI
04711467491176
Basic UDI-DI
B-04711467491176
EMDN Code
R0105020101 Tracheostomic cannulas, cuffed, not reinforced, with fixed flange, and kits
Device Class
Class IIb
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
TW-MF-000011422
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Related devices

Category: Tracheostomy tube, non-reinforced, non-customized, single-use

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Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No