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Tracheal Tube

by Well Lead Medical Co., Ltd. 113 variants

Ref A01C01752FModel Nasal Tracheal Tube, LP cuffed: 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0 mm

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Overview

A medical device directory, the Tracheal Tube is a nasal tracheal tube designed for ventilating patients who require assistance with breathing. It features advanced endocortical disruptors and sterile processing capabilities, making it an ideal solution for critical care applications.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69449327FA01C01CA Basic UDI-DI 06944932780309UDI-DIDate29 Jun 2023RegisteredStatusActive

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Nasal Tracheal Tube, LP cuffed: 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0 mm, A01C01752F
Primary DI / UDI-DI
06944932780309
Basic UDI-DI
69449327FA01C01CA
EMDN Code
R01030201 Endotracheal tubes, cuffed, not reinforced
Device Class
Class IIa
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000006728
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Related devices

Category: Basic endotracheal tube, single-use

Other devices from Well Lead Medical Co., Ltd

See all devices from Well Lead Medical Co., Ltd →

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: 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