TOOsonix A/S
DK-MF-000014211 · Denmark · Hoersholm
TOOsonix A/S is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 11 |
|---|
Most frequent device types declared: S02, SD01, SD02.
Among these devices, 9 are declared 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 | 11 |
| Country of registration | Denmark |
⚠️ 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 |
|---|---|---|
G10 004086 0003 | issued | 2029-05-12 |