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Is My7steps App certified as a medical device?

My7steps App by My7steps GmbH is listed in the German DiGA directory of reimbursed digital health apps (status: permanent), CE class I. We found no FDA authorisation.

At a glance

ProductMy7steps App
MakerMy7steps GmbH
Care areaMental health
What it doesDigital CBT programme for mild to moderate depression
FDANo FDA authorisation found
EU (CE)Class I (self-declared)
German DiGApermanent
Websitediga.my7steps.org
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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