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.
Devices declared under this manufacturer
- Acoustic Window ONE-M
- Collar ONE-M
- H03
- System ONE-M - CH
- System ONE-M - DK
- System ONE-M - IT
- System ONE-M - Schuko
- System ONE-M - UK
Catalogue references include H03 - 0.8 mm, H03 - 1.8 mm, H03 - 2.3 mm, H03-1.3 mm, S02, SD01.
European nomenclature codes declared: V9099, V9011.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 11 |
| Country of registration | Denmark |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 11 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. TOOsonix A/S was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 004086 0003 | issued | 2029-05-12 |