Wheelchair
by Danyang Sunco Machinery Co.ltd EUDAMED
Active
Ref SKW9042Model SKW8001、SKW8001-12、SKW8002、SKW8002A、SKW8002B、SKW8002C、SKW8002D、SKW8003、SKW8004、SKW8005、SKW8006、SKW8008、SKW8009、SKW8010、SKW8012、SKW8020、etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697943686WheelchairX8 | Date31 Dec 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Wheelchair
- Model / Reference
- SKW8001、SKW8001-12、SKW8002、SKW8002A、SKW8002B、SKW8002C、SKW8002D、SKW8003、SKW8004、SKW8005、SKW8006、SKW8008、SKW8009、SKW8010、SKW8012、SKW8020、etc, SKW9042
- Primary DI / UDI-DI
- 06979436861094
- Basic UDI-DI
- 697943686WheelchairX8
- EMDN Code
- Y122103 Push wheelchairs
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000051111
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Danyang Sunco Machinery Co.ltd
Properties
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