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BM Non-Rebreathing Masks
EUDAMEDClass IIa (EU MDR)
Ref 10304001Model Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard, Infant
Identity
- Trade Name
- BM Non-Rebreathing Masks EUDAMED
- Device Name
- Non-Rebreathing Masks EUDAMED
- Model / Reference
- Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard, Infant EUDAMED10304001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942382610580 EUDAMED
- Basic UDI-DI
- 697209192NBM04H9 EUDAMED
- Direct Marketing DI
- 06942382610580 EUDAMED
- EMDN Code
- R03010206 MASKS WITH RESERVOIR EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
BM Non-Rebreathing Masks by Bonree Medical Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697209192NBM04H9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bonree Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000017844
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED ff7f4716-2f05-4469-a424-ab303a2dc754 61 fields · synced Jun 19, 2026