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UNIDIX Endotracheal Tube Cuffed

by Bonree Medical Co., Ltd. EUDAMED

Active European Union

Ref 833150Model Endotracheal Tubes (Cuffed): ID 2.5mm, ID 3.0mm, ID 3.5mm, ID 4.0mm, ID 4.5mm, ID 5.0mm, ID 5.5mm, ID 6.0mm, ID 6.5mm, ID 7.0mm, ID 7.5mm, ID 8.0mm, ID 8.5mm, ID 9.0mm, ID 9.5mm, ID 10.0mm

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697209192ETTC13N8 Basic UDI-DIDate12 Jul 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Endotracheal Tubes
Model / Reference
Endotracheal Tubes (Cuffed): ID 2.5mm, ID 3.0mm, ID 3.5mm, ID 4.0mm, ID 4.5mm, ID 5.0mm, ID 5.5mm, ID 6.0mm, ID 6.5mm, ID 7.0mm, ID 7.5mm, ID 8.0mm, ID 8.5mm, ID 9.0mm, ID 9.5mm, ID 10.0mm, 833150
Primary DI / UDI-DI
06942382615219
Basic UDI-DI
697209192ETTC13N8
Direct Marketing DI
06942382615219
EMDN Code
R01030201 Endotracheal tubes, cuffed, not reinforced
Device Class
Class IIa
Market of Registration
Spain

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

Show 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