Optergo AB
SE-MF-000032762 · Sweden · Mölnlycke
Optergo AB is registered in the European database on medical devices as a manufacturer, with 62 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 62 |
|---|
Most frequent device types declared: DeLight, Optical Ergonomic Solutions.
Among these devices, 2 are declared active.
Devices declared under this manufacturer
- AddX
- DeLight Battery unit 4.0
- DeLight ProgBeam
- KepLite loupes
- PrismSpec eyeglasses
- ProSpec eyeglasses
- UltraLight Flip-up loupes
- Ultralight Flip-up loupes
- Ultralight TTL Orbit loupes
- VinKep loupes
Showing 12 of 62 declared devices.
Catalogue references include 10101, 10111, 10131, 10132, 10141, 10142.
European nomenclature codes declared: Q0299, Z129004.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 62 |
| Country of registration | Sweden |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 62 |
|---|---|
| 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. Optergo AB was not found in either the U.S. or the Canadian register.