ALTATEC GmbH
DE-MF-000006230 · Germany · Wimsheim
ALTATEC GmbH is registered in the European database on medical devices as a manufacturer, with 1 916 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 1 085 |
|---|---|
| Class IIa | 831 |
Among these devices, 986 are declared sterile, 1 085 implantable, 26 reusable.
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 | ALTATEC GMBH (DE) · FDA 9613866 |
| Devices in EUDAMED | 1 916 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G11 076870 0021 | amended | 2026-06-23 |
D1063900002 | issued | 2031-06-24 |