Reagena Oy
FI-MF-000002804 · Finland · Toivala
Reagena Oy is registered in the European database on medical devices as a manufacturer, with 50 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| other | 50 |
|---|
Most frequent device types declared: 102256SC, 102256, 102354SC, 100211, 105028SC.
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 | 50 |
| 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 |
|---|---|---|
CR-04-1235-886-25 | issued | 2030-09-22 |