Is Sleepiz One+ FDA approved or cleared?
Yes. Sleepiz One+ by Sleepiz AG is named in the FDA register with a 510(k) clearance, first authorised in 2023, 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 | Sleepiz One+ |
|---|---|
| Maker | Sleepiz AG |
| Care area | Sleep & breathing |
| What it does | Contactless bedside monitor that measures breathing, heart rate and sleep at home |
| 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 | sleepiz.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
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