Aktiia SA
CH-MF-000015833 · Switzerland · Neuchâtel
Aktiia SA is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 5 |
|---|
Most frequent device types declared: G1, G2, G2C, Hilo Spot.
Among these devices, 4 are declared active, 5 with a measuring function.
Authorised representative in the Union: Veranex Germany GmbH.
Devices declared under this manufacturer
- Hilo App (Aktiia G2C Mobile Application)
- Hilo Backend
- Hilo Band
- Hilo Band (Aktiia Bracelet G1)
- Hilo Spot (Aktiia Bracelet G2)
Catalogue references include 17649998849064, HILO BPM-004-U (S)-G1.
European nomenclature codes declared: Z1203020599,Z12030282, Z12030282, Z12030292.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | AKTIIA SA (CH) · FDA 3019575688 |
| Devices in EUDAMED | 5 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | AKTIIA SA |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 2022-07-13 |
Licence types: System (2).
Licensed under: HILO, HILO SPOT.
North American profile: Both markets. Aktiia SA is registered in both the United States and Canada.