Smartbox Assistive Technology Limited
GB-MF-000008343 · United Kingdom · Malvern
Smartbox Assistive Technology Limited is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 16 |
|---|
Most frequent device types declared: EVO Kit, Grid 3, Grid for iPad, LUMIN-I-KIT13/16, VIDA-KIT13/16.
Authorised representative in the Union: REHAVISTA GmbH.
Devices declared under this manufacturer
- EVO Kit
- Grid Pad 10s
- Grid Pad 13
- Grid Pad 16
- Grid Pad Go 10 Slim Line
- Grid Pad Go 10 Standard
- Grid for iPad
- LUMIN-I
- Talk Pad 10 - Gen 2 - Slimline
- Talk Pad 10- Gen 2
- Talk Pad 8 - Gen 2
- Talk Pad 8 - Gen 2 - Slimline
Showing 12 of 16 declared devices.
Catalogue references include EVO-KIT13/16, GP10s, GP16A, ST10E, TP08E, TP10H.
European nomenclature codes declared: Y210915, Y99, Y214224.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SMARTBOX ASSISTIVE TECHNOLOGY LTD (GB) · FDA 3012616510 |
| Devices in EUDAMED | 16 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 16 |
|---|---|
| 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: United States only. Smartbox Assistive Technology Limited is registered in the United States but was not found in the Canadian register.