Is Health Mate FDA approved or cleared?
Not as such. Withings holds a 510(k) clearance for related hardware, but Health Mate itself is not named in the FDA record.
In the EU: CE class IIa, found in EUDAMED. The manufacturer holds a valid notified body certificate under the MDR in EUDAMED.
At a glance
| Product | Health Mate |
|---|---|
| Maker | Withings |
| Care area | Vital signs & remote monitoring |
| What it does | Comprehensive health tracking app that connects with Withings devices to monitor activity, weight, heart health, and sleep |
| FDA | 510(k) (product family) |
| Verification level | Related hardware authorised; this app itself is not named (checked 18 October 2026) |
| EU (CE) | Class IIa |
| EU certificate | Manufacturer certificate from a notified body (MDR) in EUDAMED (checked 18 October 2026) |
| Website | withings.com/us/en/withings-app |
| 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