Electric Wheelchair
by Sichuan Daai Technology Co., Ltd.
Ref SK-100-W01Model SK-100-W01、SK-100-W02、SYIV100-SK-03, SYIV100-SK-04,SYIV100-SK-05,SYIV100-SK-06,SYIV100-SK-07,SYIV100-SK-08, SYIV100-SK-09, SYIV100-SK-10、SYIV100-SK-02、GDCW6XXXX-GCDW7XXXX
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697766237EW001MR 06977662370007 | Date12 Aug 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Electric Wheelchair
- Model / Reference
- SK-100-W01、SK-100-W02、SYIV100-SK-03, SYIV100-SK-04, SYIV100-SK-05, SYIV100-SK-06, SYIV100-SK-07, SYIV100-SK-08, SYIV100-SK-09, SYIV100-SK-10、SYIV100-SK-02、GDCW6XXXX-GCDW7XXXX, SK-100-W01
- Primary DI / UDI-DI
- 06977662370007
- Basic UDI-DI
- 697766237EW001MR
- EMDN Code
- Y122127 Electric wheelchairs
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000057249
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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