Happersberger otopront GmbH
DE-MF-000017407 · Germany · Hohenstein
Happersberger otopront GmbH is registered in the European database on medical devices as a manufacturer, with 70 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 70 |
|---|
Most frequent device types declared: SIT 4, RHINO-SYS, Aures Center, BASIC PLUS, TYMP modul.
Among these devices, 38 are declared active, 15 with a measuring function.
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 | HAPPERSBERGER OTOPRONT GMBH (DE) · FDA 3002807209 |
| Devices in EUDAMED | 70 |
| Country of registration | Germany |