Skip to content

Oxygen Mask

by Henan Tuoren Best Medical Device Co., Ltd. 26 variants

Ref OMI02210, OME02210, OM002210, OM001210, OMV01210, OMA03210, OME01210, OMT00210, OMV03210, OM003210, OMA01210, OMI00210, OMA02210, OMI01210, OMV00210, OMN00210, OMT02210, OMI03210, OMN03210, OMV02210, OM000210, OMO01210, OMO00210, OME00210, OMN02210, OMN01210Model Normal Mask ,Venturi Mask,Adjustable Concentration Mask,Non-breathing Mask,Tracheotomy Mask,Inflatable Mask,Nebulizer Oxygen Mask

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number694242713298FZ Basic UDI-DI Date8 Apr 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  • Withdrawn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
Oxygen Mask
Model / Reference
Normal Mask, Venturi Mask, Adjustable Concentration Mask, Non-breathing Mask, Tracheotomy Mask, Inflatable Mask, Nebulizer Oxygen Mask, OMI02210, OME02210, OM002210, OM001210, OMV01210, OMA03210, OME01210, OMT00210, OMV03210, OM003210, OMA01210, OMI00210, OMA02210, OMI01210, OMV00210, OMN00210, OMT02210, OMI03210, OMN03210, OMV02210, OM000210, OMO01210, OMO00210, OME00210, OMN02210, OMN01210
Primary DI / UDI-DI
06936186404230, 06936186404377, 06936186404018, 06936186404049, 06936186403783, 06936186403851, 06936186404407, 06936186404186, 06936186403738, 06936186404391, 06936186403981, 06936186403905, 06936186403868, 06936186404254, 06936186404308, 06936186404247, 06936186403899, 06936186404261, 06936186404193, 06936186403837, 06936186403820, 06936186403684, 06936186403929, 06936186404117, 06936186404216, 06936186403608, 06936186404315, 06936186403769, 06936186404131, 06936186404070, 06936186403813, 06936186404032, 06936186403745, 06936186404063, 06936186403615, 06936186403721, 06936186404414, 06936186404025, 06936186403653, 06936186403790, 06936186404292, 06936186404223, 06936186403677, 06936186404421
Basic UDI-DI
694242713298FZ
EMDN Code
R03010201 Air/oxygen masks
Device Class
Class IIa
EU 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
  • Reprocessed NoEUDAMEDYesEUDAMED

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: 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