EnvisionTEC GmbH
DE-MF-000009311 · Germany · Gladbeck
EnvisionTEC GmbH is registered in the European database on medical devices as a manufacturer, with 37 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 37 |
|---|
Most frequent device types declared: Flexcera Smile Ultra+, E-Guard, E-Tray, E-Guide.
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 | ENVISIONTEC GMBH (DE) · FDA 3012389497 |
| Devices in EUDAMED | 37 |
| Country of registration | Germany |