Identity
- Trade Name
- BM EUDAMED
- Device Name
- Oxygen mask EUDAMED
- Model / Reference
- M (5.8mm) EUDAMEDBM0403 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974269382051 EUDAMED
- Basic UDI-DI
- B-06974269382051 EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bm by Zhejiang Baite Medical Appliances Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06974269382051 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhejiang Baite Medical Appliances Co., Ltd.
- EUDAMED SRN
- CN-MF-000021983
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED ac6892f8-325d-43b3-a01d-9df1eac20906 61 fields · synced Jun 19, 2026