OneMed Group Oy
FI-MF-000000642 · Finland · Helsinki
OneMed Group Oy is registered in the European database on medical devices as a manufacturer, with 1 004 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 1 004 |
|---|
Most frequent device types declared: 2000020.
Among these devices, 491 are declared sterile, 1 active.
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 | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 1 004 |
| Country of registration | Finland |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
10000510541-PA-NoMA-DNK | issued | 2027-07-06 |
10000510540-PA-NoMA-DNK | issued | 2027-05-18 |