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Bizmed

by Changzhou ZhongYou Medical Device Co., Ltd. China EUDAMED

Ref 1143-OYM

EMDN R03010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697730184ZY006PJ Basic UDI-DIDate14 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Oxygen Mask / Non-Rebreathing Mask
Model / Reference
1143-OYM
Primary DI / UDI-DI
06977301840175, 06977301840199
Basic UDI-DI
697730184ZY006PJ
EMDN Code
R03010201 Air/oxygen masks
Device Class
Class IIa
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000041397
Authorised representative
Caretechion GmbH DE-AR-000005946

Other devices from Changzhou ZhongYou Medical Device Co., Ltd.

See all devices from Changzhou ZhongYou Medical Device 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 (2)

  • EUDAMED c4b9d521-0469-4344-b519-4345d543ae49 61 fields · synced 22 Oct 2026
  • EUDAMED 06977301840199|697730184ZY006PJ 61 fields · synced 20 Oct 2026