Icare Finland Oy
FI-MF-000000501 · Finland · Vantaa
Icare Finland Oy is registered in the European database on medical devices as a manufacturer, with 49 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 49 |
|---|
Most frequent device types declared: TA023, IPCL01, TP01, TA031, TP022.
Among these devices, 4 are declared sterile, 34 active, 21 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 | Icare Finland Oy (FI) · FDA 3005324856 |
| Devices in EUDAMED | 49 |
| Country of registration | Finland |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
FI22/00000011 | supplemented | 2027-10-09 |
FI22/00000011 | reissued | 2030-10-06 |