Oxygen Mask
by Henan Tuoren Best Medical Device Co., Ltd. 26 variants
Ref OME02210Model Normal Mask ,Venturi Mask,Adjustable Concentration Mask,Non-breathing Mask,Tracheotomy Mask,Inflatable Mask,Nebulizer Oxygen Mask
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number694242713298FZ | Date8 Apr 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Oxygen Mask
- Model / Reference
- Normal Mask, Venturi Mask, Adjustable Concentration Mask, Non-breathing Mask, Tracheotomy Mask, Inflatable Mask, Nebulizer Oxygen Mask, OME02210
- Primary DI / UDI-DI
- 06936186404360, 06936186404353
- 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
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