Is Onera Sleep Test System FDA approved or cleared?
Yes. Onera Sleep Test System by Onera B.V. is named in the FDA register with a 510(k) clearance, first authorised in 2022, latest decision in 2025.
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 | Onera Sleep Test System |
|---|---|
| Maker | Onera B.V. |
| Care area | Sleep & breathing |
| What it does | Patch-based sleep study (polysomnography) that patients do at home |
| FDA | 510(k), latest decision 2025 |
| 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 | onerahealth.com |
| Status | FDA verified |
| Last checked | 8 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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