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BPAP System
EUDAMEDClass IIa (EU MDR)
Ref G3 B30SVRef G2S B30TRef G2S LABRef G2S B20ARef G2S B20TRef G2S B25SRef G3 B25ARef G2S B25VTRef G3 B25S
Identity
- Trade Name
- BPAP System EUDAMED
- Device Name
- Non-Invasive Ventilator EUDAMED
- Model / Reference
- G3 B30SV EUDAMEDG2S B30T EUDAMEDG2S LAB EUDAMEDG2S B20A EUDAMEDG2S B20T EUDAMEDG2S B25S EUDAMEDG3 B25A EUDAMEDG2S B25VT EUDAMEDG3 B25S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948538365465 EUDAMED06948538365571 EUDAMED06948538365380 EUDAMED06948538365335 EUDAMED06948538365342 EUDAMED06948538365359 EUDAMED06948538365434 EUDAMED06948538365564 EUDAMED06948538365427 EUDAMED
- Basic UDI-DI
- 69485383RIV01ZL EUDAMED
- Direct Marketing DI
- 06948538365465 EUDAMED06948538365571 EUDAMED06948538365380 EUDAMED06948538365335 EUDAMED06948538365342 EUDAMED06948538365359 EUDAMED06948538365434 EUDAMED06948538365564 EUDAMED06948538365427 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 — 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 | 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 (9)
- EUDAMED f0af8272-fadc-49b0-a68a-a660dd94f374 61 fields · synced Oct 6, 2026
- EUDAMED c17437aa-f1cf-400a-a582-c268acf71c1f 61 fields · synced May 17, 2026
- EUDAMED d6cef3aa-0f30-4594-9f7a-923c743e4747 61 fields · synced May 17, 2026
- EUDAMED 7c089428-752e-4d6d-95af-1185f611140b 61 fields · synced May 18, 2026
- EUDAMED 35cd3db5-bb5f-4514-8947-c22e9e43eb34 61 fields · synced May 18, 2026
- EUDAMED ac08622e-a38d-4fcf-bdc5-a5feb9213ea5 61 fields · synced May 18, 2026
- EUDAMED 2a0eee93-62ee-4fec-9ced-3c94ba80a0a0 61 fields · synced May 18, 2026
- EUDAMED b6d97eaf-6e4c-476e-a03d-36b0bc35508e 61 fields · synced May 18, 2026
- EUDAMED eefa97c9-c176-46c7-9229-3253dc792fe3 61 fields · synced May 19, 2026