Oxygen concentrator
by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. China EUDAMED
Ref 3010706-2-1Model Oxygenate 5 (KSW-5)
EMDN Z12159004
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06934822533429 | Date31 Jul 2025 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
Specification
- Model / Reference
- Oxygenate 5 (KSW-5), 3010706-2-1
- Primary DI / UDI-DI
- 06934822533429
- Basic UDI-DI
- B-06934822533429
- EMDN Code
- Z12159004 Oxygen concentrators
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000016839
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 1dfd935f-d8ed-45f6-9f8a-7e907eedd3c1