viO HealthTech Limited
GB-MF-000008062 · United Kingdom · Camberley
viO HealthTech Limited is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 11 |
|---|
Most frequent device types declared: M026 OvuCore Vaginal Sensor, M032 OvuSense App - Android, M032 OvuSense App - iOS, M032A OvuSense App API interface, M300 OvuSense Starter Kit (OvuCore Vaginal Sensor).
Among these devices, 11 are declared active.
Authorised representative in the Union: Advena Limited.
Devices declared under this manufacturer
- OvuSense RealTime Fertility Monitor
- OvuSense Realtime Fertility Monitor
Catalogue references include M026, M032, M032A, M300, M400D, M400F.
European nomenclature codes declared: V030199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | viO HealthTech Limited (GB) · FDA 3006799946 |
| Devices in EUDAMED | 11 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 11 |
|---|---|
| Found in the U.S. device database | 5 |
| Share | 45.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | VIO HEALTHTECH LIMITED |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2016-11-14 |
Licence types: System (1).
Licensed under: OVUSENSE.
North American profile: Both markets. viO HealthTech Limited is registered in both the United States and Canada.