CareFlex Limited
GB-MF-000036001 · United Kingdom · Newton Abbott
CareFlex Limited is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 21 |
|---|
Most frequent device types declared: AlphaCare Band A Fabric. Seat width 440mm, HydroCare Band A Fabric. Seat width 380mm, HydroFlex Small, HydroTilt Mini, MultiAdjust Small.
Authorised representative in the Union: European Healthcare & Device Solutions Ltd..
Devices declared under this manufacturer
- HydroCare Band A Fabric. Seat width 480mm
- HydroFlex Medium
- HydroFlex Small
- HydroTilt Extra Large (XL)
- HydroTilt Large
- HydroTilt Medium
- HydroTilt Small
- MultiAdjust Medium
- MultiAdjust Small
- SmartSeat Medium
- SmartSeat Pro I Medium
- SmartSeat Pro I Small
Showing 12 of 21 declared devices.
Catalogue references include HydroCare Band A Fabric. Seat width 480mm, HydroFlex Medium, HydroTilt Extra Large (XL), MultiAdjust Medium, MultiAdjust Small, SmartSeat Pro I Medium.
European nomenclature codes declared: Y180999.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 21 |
| Country of registration | United Kingdom |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 21 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. CareFlex Limited was not found in either the U.S. or the Canadian register.