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Is somnovia certified as a medical device?

somnovia by GAIA AG 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

Product	somnovia
Maker	GAIA AG
Care area	Sleep & breathing
What it does	Digital CBT programme for insomnia
FDA	No FDA authorisation found
EU (CE)	Class I (self-declared)
German DiGA	permanent
Website	somnovia.de
Status	EU DiGA
Last checked	6 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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