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BM CO2 Sampling and O2 Delivery Masks
EUDAMEDClass IIa (EU MDR)
Ref 11601001Model Adult elongated; Adult standard; Pediatric elongated; Pediatric standard; Infant
Identity
- Trade Name
- BM CO2 Sampling and O2 Delivery Masks EUDAMED
- Device Name
- CO2 Sampling and O2 Delivery Masks EUDAMED
- Model / Reference
- Adult elongated; Adult standard; Pediatric elongated; Pediatric standard; Infant EUDAMED11601001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942382611181 EUDAMED
- Basic UDI-DI
- 697209192CO2M42E9 EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS 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 CO2 Sampling and O2 Delivery 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 | 697209192CO2M42E9 | 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 33b2b630-010a-413d-ac94-6124d5486c80 61 fields · synced Jul 29, 2026