Manual wheelchair
by A & I Industries Ltd Shunde Foshan China EUDAMED
Ref 108 – 23 46Model 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 EMDN Y122103
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697786880MwheelchairT8 | Date19 Sep 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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 46
- Primary DI / UDI-DI
- 06977868800384
- Basic UDI-DI
- 697786880MwheelchairT8
- EMDN Code
- Y122103 Push wheelchairs
- Device Class
- Class I
- 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 & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED f0a79a9a-3bf4-46ea-a5e4-9c7158d6437f