Identity
- Trade Name
- BPAP System EUDAMED
- Device Name
- Non-Invasive Ventilator EUDAMED
- Model / Reference
- G3 B30VT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948538365458 EUDAMED
- Basic UDI-DI
- 69485383RIV01ZL EUDAMED
- Direct Marketing DI
- 06948538365458 EUDAMED
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT 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
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
BPAP System by BMC Medical Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213169 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69485383RIV01ZL | Class IIa | Active |
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Manufacturer
- Manufacturer
- BMC Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000010157
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED e5f0c45a-f19b-4b42-82f7-5d0ed2cfd518 85 fields · synced Jun 19, 2026
- FDA 510(k) K213169 1 fields · synced May 18, 2026