Manual Wheelchair
by Hebei Manlu Medical Devices Co., Ltd.
Ref SYIV100-AModel SYIV100-A,SYIV100-GS01,SYIV100-GS02,SYIV100-GS03,SYIV100-GSR01,SYIV100-GSR02,SYIV100-GSR05,SYIV100-GSR06,SYIV100-GD01, SYIV100-GD02,SYIV100-GD03,SYIV100-GDR01,SYIV100-GDR02,SYIV100-GDR05,SYIV100-GDR06.
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 | Number697802130MLMWMH 06978021300000 | Date2 Dec 2024 | 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- Withdrawn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-A, SYIV100-GS01, SYIV100-GS02, SYIV100-GS03, SYIV100-GSR01, SYIV100-GSR02, SYIV100-GSR05, SYIV100-GSR06,SYIV100-GD01, SYIV100-GD02, SYIV100-GD03,SYIV100-GDR01, SYIV100-GDR02,SYIV100-GDR05, SYIV100-GDR06.
- Primary DI / UDI-DI
- 06978021300000
- Basic UDI-DI
- 697802130MLMWMH
- EMDN Code
- Y122103 Push wheelchairs
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000044647
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hebei Manlu Medical Devices 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