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: Accessory to Cube4D Navigation System / Instrument tracker, Accessory to Cube4D Navigation System / Navigation sensor support, hea, Accessory to Cube4D Navigation System / Registration device tactile, Accessory to Cube4D Navigation system / registration device, non-tacti, Accessory to RIWOtrack Navigation System / Instrument tracker.
Among these devices, 31 are declared active.
Devices declared under this manufacturer
- Adapter for Clipsensor
- FlexPointer
- Localizer Adhesive Pad - Single use
- Localizer K-Wire
- Navigation Headrest Horseshoe
- PointerShell 3mm
- PointerShell 4mm
- PointerShell 5mm
- PointerShell Universal
- PointerTube Kennedy
- RIWOtrack Clipsensor
- RIWOtrack Flexsensor
Showing 12 of 36 declared devices.
Catalogue references include E 01 1005, E 01 2900, E 01 2902, E 01 3202, E 10 1440, N 01 1959.
European nomenclature codes declared: Z12011480, Z12011401, Z12011485.
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 |
Device-level evidence
| Devices with a numeric GTIN | 36 |
|---|---|
| Found in the U.S. device database | 27 |
| Share | 75.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | FIAGON GMBH |
North American profile: Both markets. Fiagon GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
FI24/00000064 | issued | 2029-10-27 |