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Is levidex certified as a medical device?

levidex 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

Productlevidex
MakerGAIA AG
Care areaBrain & nerves
What it doesDigital programme supporting people with multiple sclerosis after diagnosis
FDANo FDA authorisation found
EU (CE)Class I (self-declared)
German DiGApermanent
Websitelevidex.de
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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