GE Healthcare Austria GmbH & Co OG
AT-MF-000001461 · Austria · ZIPF
GE Healthcare Austria GmbH & Co OG is registered in the European database on medical devices as a manufacturer, with 26 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 26 |
|---|
Most frequent device types declared: Voluson Expert 18, Voluson Expert 20, Voluson Expert 22, C2-9-RS, RAB6-RS, RIC5-9-D, eM6C G3.
Among these devices, 25 are declared active, 14 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 | GE Healthcare Austria GmbH & Co OG (AT) · FDA 8020021 |
| Devices in EUDAMED | 26 |
| Country of registration | Austria |