Identity
- Trade Name
- Oxygen Concentrator EUDAMED
- Device Name
- Oxygen Concentrator EUDAMED
- Model / Reference
- SO1 5B EUDAMEDSO1 5A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948538369067 EUDAMED06948538369050 EUDAMED
- Basic UDI-DI
- 69485383OC001RG EUDAMED
- Direct Marketing DI
- 06948538369067 EUDAMED06948538369050 EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMEDCroatia 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
Oxygen Concentrator by BMC Medical Co., Ltd. — Class IIb — 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 | 69485383OC001RG | Class IIb | 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 cd5f0291-7fe7-4ffb-be7d-e265b1e92d95 61 fields · synced Jul 29, 2026
- EUDAMED 59273e5d-0312-455a-9535-83d66f8f2b69 61 fields · synced May 17, 2026