Is BrainEye certified as a medical device?
BrainEye by Neuro Optica (BrainEye) is listed as a CE class I medical device. Class I is self-declared by the maker, without review by a notified body. We found no FDA authorisation.
At a glance
| Product | BrainEye |
|---|---|
| Maker | Neuro Optica (BrainEye) |
| Care area | Brain & nerves |
| What it does | Smartphone app that screens for concussion by measuring eye movements |
| FDA | No FDA authorisation found |
| EU (CE) | Class I (self-declared) |
| Website | braineye.com |
| Status | CE class I |
| Last checked | 7 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
Other apps in Brain & nerves
- Brainomix 360
- BrainScope
- Cala Trio
- CANTAB Insight
- CT-132
- EmbracePlus
- Empatica Parkinson's Monitoring (PKG Monitor)
- Encora X1
All certified apps and devices for brain and nerve conditions