Sunrise SA
BE-MF-000000105 · Belgium · Namur
Sunrise SA is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 5 |
|---|
Most frequent device types declared: SUN100, SUN1xx.
Among these devices, 5 are declared active, 1 with a measuring function.
Devices declared under this manufacturer
- Sunrise Sleep Disorder Diagnostic Aid
- Sunrise sensor
Catalogue references include A200, A201, A202, A203, SUN1xx.
European nomenclature codes declared: Z1399, V92.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SUNRISE SA (BE) · FDA 3022505448 |
| Devices in EUDAMED | 5 |
| Country of registration | Belgium |
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 20.0 % |
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. Sunrise SA is registered in the United States but was not found in the Canadian register.