Manual wheelchair
by A & I Industries Ltd Shunde Foshan 84 variants
Ref 108 – 23 51Model 3001, 3002, 218-23, 218-23 WHD, 118-23, 118-23 Plus, 218-24, 108-23, Primeo, Primeo Plus, 348-23, 318-23, Relax Comfort, 358-23, 228-24 J, 538-23, 538-23 Hemi, 538-23 Comfort
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 | Number697786880MwheelchairT8 06977868800407 | Date19 Sep 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- Withdrawn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
- 3001, 3002, 218-23, 218-23 WHD, 118-23, 118-23 Plus, 218-24, 108-23, Primeo, Primeo Plus, 348-23, 318-23, Relax Comfort, 358-23, 228-24 J, 538-23, 538-23 Hemi, 538-23 Comfort, 108 – 23 51
- Primary DI / UDI-DI
- 06977868800407
- Basic UDI-DI
- 697786880MwheelchairT8
- EMDN Code
- Y122103 Push wheelchairs
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000038647
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from A & I Industries Ltd Shunde Foshan
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