Is mdbrain certified as a medical device?
mdbrain by mediaire GmbH is listed in EUDAMED as a CE class IIb medical device. No notified body certificate is visible in EUDAMED yet; ask the maker for it (devices still under the older MDD rules often have none listed). We found no FDA authorisation.
At a glance
| Product | mdbrain |
|---|---|
| Maker | mediaire GmbH |
| Care area | Imaging & AI diagnostics |
| What it does | AI software for automated brain MRI analysis: volumetry and lesion detection |
| FDA | No FDA authorisation found |
| EU (CE) | Class IIb |
| EU certificate | Not visible in EUDAMED yet (checked 18 October 2026) |
| Website | mediaire.de |
| Status | CE verified |
| 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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