Is elona explore certified as a medical device?
elona explore by Elona Health GmbH is listed in the German DiGA directory of reimbursed digital health apps (status: provisional), CE class I. We found no FDA authorisation.
At a glance
| Product | elona explore |
|---|---|
| Maker | Elona Health GmbH |
| Care area | Mental health |
| What it does | Digital therapy companion for depression and anxiety, used alongside psychotherapy |
| FDA | No FDA authorisation found |
| EU (CE) | Class I (self-declared) |
| German DiGA | provisional |
| Website | elona.health/elona-explore-patienten |
| Status | EU DiGA |
| Last checked | 6 October 2026 |
Need the evidence behind this entry?
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
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