Oxygen concentrator
by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. China EUDAMED
Ref KSI-5Model KSW-5,KSJ-5,KSI-5,KSQ-5
EMDN Z12159004
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number693482256810JL | Date27 Sep 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Oxygen concentrator
- Model / Reference
- KSW-5, KSJ-5, KSI-5, KSQ-5
- Primary DI / UDI-DI
- 06934822532040
- Basic UDI-DI
- 693482256810JL
- Direct Marketing DI
- 06934822532040
- EMDN Code
- Z12159004 Oxygen concentrators
- Device Class
- Class IIb
- 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 (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 06934822532040|693482256810JL