Is OraQ AI certified as a medical device?
We could not confirm the certification that OraQ AI 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 | OraQ AI |
|---|---|
| Maker | OraQ Technologies |
| Care area | Other |
| What it does | AI-powered oral health assessment platform using smartphone camera |
| FDA | No FDA authorisation found |
| EU (CE) | No CE listing found |
| Website | oraq.ai |
| 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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