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.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
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 |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 045226 0013 | issued | 2031-07-09 |