Manual wheelchair
by Zhongshan Sulenz Intelligent Technology Co., LTD 3 variants
Ref SYIV100-SLS100Model SYIV100-SLS100 SYIV100-SLS200 SYIV100-SLS300
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 | Number697679131MwheelchairDG 06976791310120 | Date24 Apr 2025 | 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- Withdrawn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
- Manual wheelchair
- Model / Reference
- SYIV100-SLS100 SYIV100-SLS200 SYIV100-SLS300, SYIV100-SLS100
- Primary DI / UDI-DI
- 06976791310120
- Basic UDI-DI
- 697679131MwheelchairDG
- EMDN Code
- Y122103 Push wheelchairs
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000047504
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Zhongshan Sulenz Intelligent Technology Co., LTD
See all devices from Zhongshan Sulenz Intelligent Technology 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