Sleepiz AG
CH-MF-000011783 · Switzerland · Zurich
Sleepiz AG is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 6 |
|---|
Most frequent device types declared: 1.0, 2.5, 3.0.
Among these devices, 6 are declared active.
Authorised representative in the Union: MED-RAS GmbH Regulatory Affairs Service.
Devices declared under this manufacturer
- Sleepiz One+
- Sleepiz One+ Connect
Catalogue references include 04, 05, 09, 1.0, 30, 40.
European nomenclature codes declared: Z12030280, Z12030282, Z129011.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Sleepiz AG (CH) · FDA 3020207731 |
| Devices in EUDAMED | 6 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 6 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 16.7 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. Sleepiz AG is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 104055 0002 | issued | 2026-11-15 |