Is icompanion certified as a medical device?
icompanion by icometrix is listed in EUDAMED as a CE class IIa medical device. The manufacturer holds a valid notified body certificate under the MDR in EUDAMED. We found no FDA authorisation.
At a glance
| Product | icompanion |
|---|---|
| Maker | icometrix |
| Care area | Brain & nerves |
| What it does | App for people with multiple sclerosis to track symptoms and share brain MRI results |
| FDA | No FDA authorisation found |
| EU (CE) | Class IIa |
| EU certificate | Manufacturer certificate from a notified body (MDR) in EUDAMED (checked 18 October 2026) |
| Website | icometrix.com |
| Status | CE verified |
| 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