Stylite Designs
IE-MF-000035101 · Ireland · Cork
Stylite Designs is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 7 |
|---|
Most frequent device types declared: FreeWheeler (Standard & Titanium), Headrest Shell (S, S/M, M, L), PiVoT (Model A & S), Scamp GTT, Sit-Right Backrest.
Devices declared under this manufacturer
- Stylite Designs Ltd
Catalogue references include FreeWheeler (Standard & Titanium), Headrest Shell (S, S/M, M, L), PiVoT, Scamp GTT, Sit-Right Cushion, Sit-Right backrest.
European nomenclature codes declared: Y122106, Y122406, Y122403.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 7 |
| Country of registration | Ireland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 7 |
|---|---|
| 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. Stylite Designs was not found in either the U.S. or the Canadian register.