Sunstar Europe SA
CH-MF-000023162 · Switzerland · Etoy
Sunstar Europe SA is registered in the European database on medical devices as a manufacturer, with 19 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 19 |
|---|
Most frequent device types declared: 2400EPA, 2400FNLDA, 2410EPIGBA, 2410FNLDSCA, 2420EPGBA.
Among these devices, 2 are declared active.
Authorised representative in the Union: Sunstar France.
Devices declared under this manufacturer
- BUTLER GRINDCARE DEVICE
- BUTLER PALPETER
- Butler Grindcare Gelpad
- GUM AFTA CLEAR GEL
- GUM AFTACLEAR GEL
- GUM AFTACLEAR RINSE
- GUM AFTACLEAR SPRAY
- GUM HYDRAL GEL
- GUM HYDRAL MOUTHRINSE
- GUM HYDRAL SPRAY
- GUM HYDRAL TOOTHPASTE
- GUM Ortho Wax
Showing 12 of 19 declared devices.
Catalogue references include 2400EPA, 2400FNLDA, 2410EPIGBA, 2410FNLDSCA, 2420SCA, 723BX.
European nomenclature codes declared: M040499, V9099, Q01020203, Z12062401, Z12062485, Z12040101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 19 |
| Country of registration | Switzerland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 19 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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: Neither register. Sunstar Europe SA was not found in either the U.S. or the Canadian register.