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Is Ovy App certified as a medical device?

Ovy App by Ovy GmbH is listed in EUDAMED as a CE class IIb medical device. The manufacturer holds a valid notified body certificate under the MDR in EUDAMED. We found no FDA authorisation.

At a glance

Product	Ovy App
Maker	Ovy GmbH
Care area	Women's health & fertility
What it does	Cycle and fertility tracking app based on basal body temperature
FDA	No FDA authorisation found
EU (CE)	Class IIb
EU certificate	Manufacturer certificate from a notified body (MDR) in EUDAMED (checked 18 October 2026)
Website	ovyapp.com
Status	CE verified
Last checked	7 October 2026

Certification status can change. Always confirm in the official register before relying on it: the FDA databases, EUDAMED or the BfArM DiGA directory.

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