EU → US Device Access

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 IIa11

Most frequent device types declared: M032A OvuSense App API interface, M400W OvuSense Starter Kit (OvuFirst Skin Worn Sensor with wrist band), M032 OvuSense App - iOS, M300 OvuSense Starter Kit (OvuCore Vaginal Sensor), M026 OvuCore Vaginal Sensor.

Among these devices, 11 are declared active.

Authorised representative in the Union: MT-AR-000000234.

United States market access

FDA establishment registerRegistered with FDA
Matched entryviO HealthTech Limited (GB) · FDA 3006799946
Devices in EUDAMED11
Country of registrationUnited Kingdom

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