Is Brain Check certified as a medical device?
We could not confirm the certification that Brain Check claims in the FDA register, EUDAMED or the German DiGA directory. It is on our public watchlist until the maker provides a reference number we can verify.
In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.
At a glance
| Product | Brain Check |
|---|---|
| Maker | BrainCheck Inc |
| Care area | Brain & nerves |
| What it does | Cognitive assessment platform for brain health screening and monitoring |
| FDA | No FDA authorisation found |
| EU (CE) | No CE listing found |
| Website | braincheck.com |
| Status | Watchlist |
| 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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