Topcon Healthcare Solutions EMEA Oy
FI-MF-000004775 · Finland · Oulu
Topcon Healthcare Solutions EMEA Oy is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 8 |
|---|
Among these devices, 8 are declared active.
Devices declared under this manufacturer
- Harmony RS
- RDx
Catalogue references include 06430078740005, v2.0, v2.7, v2.8, v2.9, v3.10.0.
European nomenclature codes declared: V92.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Topcon Healthcare Solutions EMEA Oy (FI) · FDA 3014926240 |
| Devices in EUDAMED | 8 |
| Country of registration | Finland |
Device-level evidence
| Devices with a numeric GTIN | 8 |
|---|---|
| Found in the U.S. device database | 3 |
| Share | 37.5 % |
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: United States only. Topcon Healthcare Solutions EMEA Oy is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
10000473385-PA-NoMA-DNK | issued | 2030-04-10 |