Manual Wheelchair
by Zhongshan First Medical Equipment Co., Ltd 3 variants
Ref FST6700Model SYⅣ100-YC2000、SYⅣ100-YC3000W、SYⅣ100-2000H20、SYⅣ100-2000W 、FST610、FST6700、FST3000、FST2000、FST870、FST874、FST6600 or customized
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 | Number697584560FST002S2 06975845600163 | Date18 Feb 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- Withdrawn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-YC2000、SYⅣ100-YC3000W、SYⅣ100-2000H20、SYⅣ100-2000W 、FST610、FST6700、FST3000、FST2000、FST870、FST874、FST6600 or customized, FST6700
- Primary DI / UDI-DI
- 06975845600163
- Basic UDI-DI
- 697584560FST002S2
- EMDN Code
- Y122103 Push wheelchairs
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000044385
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Zhongshan First Medical Equipment Co., Ltd
See all devices from Zhongshan First Medical Equipment 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