Oxygen mask with reservoir and tube
by Bonree Medical Co., Ltd. 3 variants
Ref \Model Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard, Infant
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 | Number697209192NBM04H9 06942382601830 | Date10 Oct 2025 | 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- Withdrawn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
- Non-Rebreathing Masks
- Model / Reference
- Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard, Infant, \
- Primary DI / UDI-DI
- 06942382601830
- Basic UDI-DI
- 697209192NBM04H9
- Direct Marketing DI
- 06942382601830
- EMDN Code
- R03010206 Masks with reservoir
- Device Class
- Class IIa
- EU market of registration
- Poland
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.
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