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: E-Guard, E-Guide, E-Tray, Flexcera Smile Ultra+.
Devices declared under this manufacturer
- E-Guard
- E-Guide
- E-Tray
- Flexcera Base Light Pink
- Flexcera Base Original Pink
- Flexcera Base Ultra+ Dark Pink
- Flexcera Smile A1
- Flexcera Smile A3
- Flexcera Smile Ultra+ A1 1kg for Carbon
- Flexcera Smile Ultra+ A2 1kg for Carbon
- Flexcera Smile Ultra+ A3 0.5kg
- Flexcera Smile Ultra+ A3.5 0.5kg
Showing 12 of 37 declared devices.
Catalogue references include RES-01-3213, RES-01-3214, RES-01-3236, RES-01-3240, RES-01-3243, RES-01-3285.
European nomenclature codes declared: Q010699.
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 |
Device-level evidence
| Devices with a numeric GTIN | 37 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ENVISIONTEC GMBH |
North American profile: Both markets. EnvisionTEC GmbH is registered in both the United States and Canada.