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Is Oviva Direkt Bluthochdruck certified as a medical device?

Oviva Direkt Bluthochdruck by Oviva AG is listed in the German DiGA directory of reimbursed digital health apps (status: provisional), CE class IIa. We found no FDA authorisation.

At a glance

ProductOviva Direkt Bluthochdruck
MakerOviva AG
Care areaHeart & circulation
What it doesDigital lifestyle therapy for high blood pressure
FDANo FDA authorisation found
EU (CE)Class IIa
EU certificateNot found in EUDAMED (checked 18 October 2026)
German DiGAprovisional
Websiteoviva.com/de/de/direkt-bluthochdruck
StatusEU DiGA
Last checked6 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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