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UNIDIX Intubating Stylet

by Bonree Medical Co., Ltd. China EUDAMED

Ref 833210Model Solid: 6Fr, 10Fr, 15Fr ;Hollow: 10Fr, 15Fr

EMDN R018004

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697209192ETI17HR Basic UDI-DIDate24 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Endotracheal Tube Introducers (bougie)
Model / Reference
Solid: 6Fr, 10Fr, 15Fr, Hollow: 10Fr, 833210
Primary DI / UDI-DI
06942382615332
Basic UDI-DI
697209192ETI17HR
Direct Marketing DI
06942382615332
EMDN Code
R018004 Intubation device guides
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 06942382615332|697209192ETI17HR 61 fields · synced 24 Oct 2026