BM Non-Rebreathing Masks
by Bonree Medical Co., Ltd. China EUDAMED
Ref 10301001Model Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard, Infant, Adult Standard, Pediatric Standard, Adult Elongated, Pediatric Elongated EMDN R03010206
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | Number697209192NBM04H9 | Date10 Oct 2025 | StatusActive |
| European Union | CE/MDR | Number697209192NBM04H9 | Date10 Oct 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD, CE/MDR Active
Specification
- Trade Name
- BM Non-Rebreathing MasksNon-Rebreathing Masks
- Model / Reference
- Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard, Infant, 10301001
- Primary DI / UDI-DI
- 06942382610559, D-NBM04XQ
- Basic UDI-DI
- 697209192NBM04H9, B-NBM04XQ
- Direct Marketing DI
- 06942382610559
- EMDN Code
- R03010206 Masks with reservoir
- Device Class
- Class IIa
- Market of Registration
- PolandRomania
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 & raw data
Show properties, registry sources and raw records
Other properties (11)
- Implantable: No
- Reusable: 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 16b3bbd9-a71a-42d0-8a9e-416acd0cac8f
- EUDAMED D-NBM04XQ|B-NBM04XQ