Is Corsano CardioWatch FDA approved or cleared?
Yes. Corsano CardioWatch by Corsano Health B.V. is named in the FDA register with a 510(k) clearance, first authorised in 2024, latest decision in 2026.
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 | Corsano CardioWatch |
|---|---|
| Maker | Corsano Health B.V. |
| Care area | Vital signs & remote monitoring |
| What it does | Medical-grade wrist wearable for continuous remote vital signs monitoring |
| FDA | 510(k), latest decision 2026 |
| Verification level | Exact product named in the FDA record (checked 18 October 2026) |
| EU (CE) | Class IIa |
| EU certificate | Manufacturer certificate from a notified body (MDR) in EUDAMED (checked 18 October 2026) |
| Website | corsano.com |
| Status | FDA 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