Is MouthLab FDA approved or cleared?
Yes. MouthLab by Aidar Health (Multisensor Diagnostics) is named in the FDA register with a 510(k) clearance, latest decision in 2021.
In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.
At a glance
| Product | MouthLab |
|---|---|
| Maker | Aidar Health (Multisensor Diagnostics) |
| Care area | Vital signs & remote monitoring |
| What it does | Handheld device that measures vital signs through the mouth and fingertips |
| FDA | 510(k), latest decision 2021 |
| Verification level | Exact product named in the FDA record (checked 18 October 2026) |
| EU (CE) | No CE listing found |
| Website | aidar.com/solutions |
| Status | FDA 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