Optomed Oyj
FI-MF-000009407 · Finland · Oulu
Optomed Oyj is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 21 |
|---|
Most frequent device types declared: Aurora, Aurora camera, Optomed Aurora, Signal, Signal Camera.
Among these devices, 18 are declared active.
Devices declared under this manufacturer
- Optomed Aurora
- Optomed Aurora camera
- Optomed E-safe
- Optomed Lumo Camera
- Optomed Lumo Charging Station
- Optomed Lumo Desktop Base
- Optomed Smartscope
- Signal Camera
- Smartscope
- Topcon Signal
- Visuscout 100
Showing 12 of 21 declared devices.
Catalogue references include 31000063, 31000065, 41000023, 41000040, 41000651, 41001595.
European nomenclature codes declared: Z119007, Z119003, Z119080, Z119085, Z12120199, Z12120180.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Optomed (FI) · FDA 3007710608 |
| Devices in EUDAMED | 21 |
| Country of registration | Finland |
Device-level evidence
| Devices with a numeric GTIN | 21 |
|---|---|
| Found in the U.S. device database | 4 |
| Share | 19.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | OPTOMED OYJ |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 2020-01-22 |
Licence types: System (2).
Licensed under: OPTOMED AURORA, OPTOMED LUMO CAMERA.
North American profile: Both markets. Optomed Oyj is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
FI24/00000061 | supplemented | 2029-06-05 |
FI24/00000061 | reissued | 2030-06-16 |