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oxygenate
EUDAMEDClass IIa (EU MDR)
Ref KSOC-10Model KSOC-10 （230V 50Hz）
by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
Identity
- Trade Name
- oxygenate EUDAMED
- Device Name
- Oxygen concentrator EUDAMED
- Model / Reference
- KSOC-10 （230V 50Hz） EUDAMEDKSOC-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934822532149 EUDAMED
- Basic UDI-DI
- B-06934822532149 EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
oxygenate by Jiangsu Konsung Bio-Medical Science And Technology 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-06934822532149 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000016839
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED e02a78a7-3215-492c-8c8f-07c25cfd49d2 61 fields · synced Jun 18, 2026