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Oxygen Concentrator
EUDAMEDClass IIa (EU MDR)
Ref 6810Model KSOC-5Model KSN-5
by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
Identity
- Device Name
- Oxygen Concentrator EUDAMED
- Model / Reference
- KSOC-5 EUDAMED6810 EUDAMEDKSN-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934822531364 EUDAMED06934822531357 EUDAMED
- Basic UDI-DI
- B-06934822531364 EUDAMEDB-06934822531357 EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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
Oxygen Concentrator 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-06934822531364 | 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 (2)
- EUDAMED 365b531c-7d79-4db6-aae0-d096604c281f 61 fields · synced Oct 6, 2026
- EUDAMED 34b3b720-07b7-4fb1-81e6-2e8dac0ad77b 61 fields · synced Jul 18, 2026