WHITEsmile GmbH
DE-MF-000018734 · Germany · Birkenau
WHITEsmile GmbH is registered in the European database on medical devices as a manufacturer, with 49 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 49 |
|---|
Among these devices, 3 are declared active.
Devices declared under this manufacturer
- WHITEsmile After Whitening Mousse
- WHITEsmile fläsh After Whitening Mousse
Showing 12 of 49 declared devices.
Catalogue references include 000891, 3102, 3106, 3492, 3500, 5701.
European nomenclature codes declared: Q010199, L150201, Q019008, Z12110101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | WHITEsmile GMBH (DE) · FDA 3014545089 |
| Devices in EUDAMED | 49 |
| Country of registration | Germany |
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. WHITEsmile GmbH is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 045226 0013 | issued | 2031-07-09 |