Hemodialysis Equipment
by SWS Hemodialysis Care Co., Ltd. China EUDAMED
Ref SWS-5000B, SWS-4000, SWS-5000A, SWS-5000, SWS-6000, SWS-6000A, SWS-4000A EMDN Z12090201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69557484SWS-5000E7 | Date17 Mar 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- SWS-5000B, SWS-4000, SWS-5000A, SWS-5000, SWS-6000, SWS-6000A, SWS-4000A
- Primary DI / UDI-DI
- 06955748410526, 06955748410403, 06955748410519, 06955748410502, 06955748410601, 06955748410618, 06955748410410
- Basic UDI-DI
- 69557484SWS-5000E7, 69557484SWS-4000DY, 69557484SWS-6000EE
- Direct Marketing DI
- 06955748410526069557484104030695574841051906955748410502069557484106010695574841061806955748410410
- EMDN Code
- Z12090201 Haemodialysis equipment
- Device Class
- Class IIb
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000024516
- Authorised representative
- MedPath GmbH DE-AR-000000087
Other devices from SWS Hemodialysis Care Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- 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
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (7)
- EUDAMED 55c27cd9-f891-4a53-9d84-69e61799e16e
- EUDAMED 06955748410403|69557484SWS-4000DY
- EUDAMED 06955748410519|69557484SWS-5000E7
- EUDAMED 06955748410502|69557484SWS-5000E7
- EUDAMED 06955748410601|69557484SWS-6000EE
- EUDAMED 06955748410618|69557484SWS-6000EE
- EUDAMED 06955748410410|69557484SWS-4000DY