Sivantos GmbH
DE-MF-000014326 · Germany · Erlangen
Sivantos GmbH is registered in the European database on medical devices as a manufacturer, with 802 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 802 |
|---|
Most frequent device types declared: RIC, BTE, CUSTOM, INSTANT FIT, SLIM RIC.
Among these devices, 802 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 | Sivantos GmbH (DE) · FDA 3005019184 |
| Devices in EUDAMED | 802 |
| Country of registration | Germany |