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Is HelloBetter Schlafen certified as a medical device?

HelloBetter Schlafen by GET.ON Institut für Online Gesundheitstrainings 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

Product	HelloBetter Schlafen
Maker	GET.ON Institut für Online Gesundheitstrainings GmbH
Care area	Sleep & breathing
What it does	Online CBT course for insomnia
FDA	No FDA authorisation found
EU (CE)	Class I (self-declared)
German DiGA	permanent
Website	hellobetter.de/online-kurse/schlafen
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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