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Oxygenate
EUDAMEDClass IIa (EU MDR)
Ref Oxygenate 5（KSW-5）Model KSW-5Ref KSOC-10Model KSOC-10(230V 50Hz）Ref Oxygenate 5（KSW-5)Model KSW-5 (220V, 50Hz, Philips）
by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
Identity
- Trade Name
- Oxygenate EUDAMED
- Device Name
- Oxygen Concentrator EUDAMED
- Model / Reference
- KSW-5 EUDAMEDOxygenate 5（KSW-5） EUDAMEDKSOC-10(230V 50Hz） EUDAMEDKSOC-10 EUDAMEDKSW-5 (220V, 50Hz, Philips） EUDAMEDOxygenate 5（KSW-5) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934822532132 EUDAMED06934822532125 EUDAMED06934822533337 EUDAMED
- Basic UDI-DI
- B-06934822532132 EUDAMEDB-06934822532125 EUDAMEDB-06934822533337 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-06934822532132 | 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 (3)
- EUDAMED 9b138a8e-c7e1-46b4-9f80-8429b26d1ccb 61 fields · synced Jul 29, 2026
- EUDAMED fb47976b-6605-4e66-a2c0-ac168dce9e2f 61 fields · synced May 18, 2026
- EUDAMED 83e7c7b4-5764-4aab-b2a8-39a81b18ae8b 61 fields · synced May 18, 2026