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philips
EUDAMEDClass IIa (EU MDR)
Ref oxygenate 10Model KSOC-10Ref Oxygenate10
by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
Identity
- Trade Name
- philips EUDAMED
- Device Name
- oxygen concentrator EUDAMED
- Model / Reference
- KSOC-10 EUDAMEDoxygenate 10 EUDAMEDOxygenate10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934822533399 EUDAMED06934822533412 EUDAMED
- Basic UDI-DI
- B-06934822533399 EUDAMEDB-06934822533412 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
philips 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-06934822533399 | 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 f283b64c-c652-44ab-ac2e-45137a5e5dc7 61 fields · synced Jul 11, 2026
- EUDAMED d89c598e-1cb2-4a4b-a2bb-84cab9eaa161 61 fields · synced May 18, 2026