Is Somfit FDA approved or cleared?
Yes. Somfit by Compumedics Limited is named in the FDA register with a 510(k) clearance, first authorised in 2023, latest decision in 2025.
In the EU: CE class IIa, found in EUDAMED. No notified body certificate is visible in EUDAMED yet; ask the maker for it (devices still under the older MDD rules often have none listed).
At a glance
| Product | Somfit |
|---|---|
| Maker | Compumedics Limited |
| Care area | Sleep & breathing |
| What it does | Forehead patch with app for at-home sleep testing and sleep staging |
| 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 | Not visible in EUDAMED yet (checked 18 October 2026) |
| Website | compumedics.com.au/en/products/somfit |
| 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
Other apps in Sleep & breathing
- AcuPebble™ Ox100
- Aevice Wheeze Detection Module
- AeviceMD
- AireHealth Nebulizer
- ANNE Sleep
- Apple Watch Sleep Apnea Notifications
- Belun Ring
- CapMedic