Planmeca Oy
FI-MF-000006499 · Finland · Helsinki
Planmeca Oy is registered in the European database on medical devices as a manufacturer, with 47 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 26 |
|---|---|
| Class IIa | 21 |
Among these devices, 43 are declared active, 7 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 | Planmeca Oy (FI) · FDA 8030876 |
| Devices in EUDAMED | 47 |
| Country of registration | Finland |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
FI23/00000059 | supplemented | 2028-12-27 |
FI23/00000059 | supplemented | 2030-06-26 |