Fiagon GmbH
DE-MF-000010763 · Germany · Hennigsdorf
Fiagon GmbH is registered in the European database on medical devices as a manufacturer, with 36 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 36 |
|---|
Most frequent device types declared: Cube 4D Navigation System, RIWOtrack Navigation System, Accessory to Cube4D Navigation System / Instrument tracker, Accessory to RIWOtrack Navigation System / adapter, Accessory to RIWOtrack Navigation System / Instrument tracker.
Among these devices, 31 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 | Fiagon GMBH (DE) · FDA 3010313588 |
| Devices in EUDAMED | 36 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
FI24/00000064 | issued | 2029-10-27 |