Identity
- Trade Name
- Oxygen concentrator EUDAMED
- Device Name
- Oxygen concentrator EUDAMED
- Model / Reference
- OCB-5,OCB-5R EUDAMEDOCB-5R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942820422355 EUDAMED
- Basic UDI-DI
- 69428204OXCTWS EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIb 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Oxygen concentrator by Beijing Choice Electronic Technology 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 | 69428204OXCTWS | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Choice Electronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005776
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED b67c2bb6-b891-4f59-9e89-ffff8094c754 61 fields · synced Jun 18, 2026