PaloDEx Group Oy
FI-MF-000004943 · Finland · Tuusula
PaloDEx Group Oy is registered in the European database on medical devices as a manufacturer, with 98 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 74 |
|---|---|
| Class IIb | 24 |
Most frequent device types declared: PCX-1, OP300-1, Focus, eXam 6-1, DXR-50.
Among these devices, 30 are declared active, 2 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 | PALODEX GROUP OY (FI) · FDA 3005383085 |
| Devices in EUDAMED | 98 |
| Country of registration | Finland |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CR-03-1154-812-23 | supplemented | 2028-03-06 |