Is Samsung Health ECG monitor FDA approved or cleared?
Yes. Samsung Health ECG monitor by Samsung Electronics Co., Ltd. is named in the FDA register with a 510(k) clearance, first authorised in 2020, latest decision in 2024.
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 | Samsung Health ECG monitor |
|---|---|
| Maker | Samsung Electronics Co., Ltd. |
| Care area | Heart & circulation |
| What it does | Electrocardiogram monitoring feature on Samsung Galaxy Watch devices |
| FDA | 510(k), latest decision 2024 |
| 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 | samsung.com |
| Status | FDA verified |
| Last checked | 6 October 2026 |
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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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