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Is somnio certified as a medical device?

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

At a glance

Product	somnio
Maker	mementor DE GmbH
Care area	Sleep & breathing
What it does	Digital therapeutic app for chronic insomnia using evidence-based CBT
FDA	No FDA authorisation found
EU (CE)	Class IIa
EU certificate	Manufacturer certificate from a notified body (MDR) in EUDAMED (checked 18 October 2026)
German DiGA	permanent
Website	somn.io
Status	EU DiGA
Last checked	1 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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