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BM Tracheostomy Tubes

by Bonree Medical Co., Ltd. 30 variants

Ref 22385002Model Uncuffed, ID: 3.0mm，ID: 3.5mm，ID: 4.0mm，ID: 4.5mm，ID: 5.0mm, 5.5mm, 6.0mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm,9.0mm, 9.5mm, 10.0mm

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697209192TTTU35XF Basic UDI-DI 06972091921448UDI-DIDate26 May 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Tracheostomy Tubes
Model / Reference
Uncuffed, ID: 3.0mm，ID: 3.5mm，ID: 4.0mm，ID: 4.5mm，ID: 5.0mm, 5.5mm, 6.0mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 9.5mm, 10.0mm, 22385002
Primary DI / UDI-DI
06972091921448
Basic UDI-DI
697209192TTTU35XF
Direct Marketing DI
06972091921448
EMDN Code
R0105010101 Tracheostomic cannulas, cuffless, not reinforced, with fixed flange, and kits
Device Class
Class IIa
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000017844
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Bonree Medical Co., Ltd.

See all devices from Bonree 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