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Oxygen Mask

by Henan Tuoren Best Medical Device Co., Ltd. EUDAMED

Active European Union

Ref OMN00210Model Normal Mask ,Venturi Mask,Adjustable Concentration Mask,Non-breathing Mask,Tracheotomy Mask,Inflatable Mask,Nebulizer Oxygen Mask

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number694242713298FZ Basic UDI-DIDate8 Apr 2026RegisteredStatusActive

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  • Withdrawn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
Oxygen Mask
Model / Reference
Normal Mask, Venturi Mask, Adjustable Concentration Mask, Non-breathing Mask, Tracheotomy Mask, Inflatable Mask, Nebulizer Oxygen Mask, OMN00210
Primary DI / UDI-DI
06936186403707, 06936186403691, 06936186403714
Basic UDI-DI
694242713298FZ
EMDN Code
R03010201 Air/oxygen masks
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000007452
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Henan Tuoren Best Medical Device Co., Ltd.

See all devices from Henan Tuoren Best Medical Device 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