Inion Oy
FI-MF-000000646 · Finland · Tampere
Inion Oy is registered in the European database on medical devices as a manufacturer, with 1 053 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 540 |
|---|---|
| Class IIa | 512 |
| Class IIb | 1 |
Most frequent device types declared: PCK-7002, OPK-20K3, OPK-15K3, OPK-15K1, OPK-20K2.
Among these devices, 544 are declared sterile, 539 implantable, 510 reusable, 55 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 | INION OY (FI) · FDA 9710629 |
| Devices in EUDAMED | 1 053 |
| Country of registration | Finland |