Is Smartheart certified as a medical device?
Smartheart by Smartheart Inc is listed in EUDAMED as a CE class IIa medical device. A notified body certificate is linked to the device record in EUDAMED. We found no FDA authorisation.
At a glance
| Product | Smartheart |
|---|---|
| Maker | Smartheart Inc |
| Care area | Heart & circulation |
| What it does | Cardiac monitoring and heart health management platform |
| FDA | No FDA authorisation found |
| EU (CE) | Class IIa |
| EU certificate | Linked to the device record in EUDAMED (checked 18 October 2026) |
| Website | smartheartpro.com |
| 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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