Ikerian AG
CH-MF-000014537 · Switzerland · Bern
Ikerian AG is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 6 |
|---|---|
| Class IIb | 1 |
Most frequent device types declared: OCT Atlas 4.0.0.
Among these devices, 6 are declared active.
Authorised representative in the Union: Blue Broccoli GmbH.
Devices declared under this manufacturer
- LuxIA
- RetinAI Macula Biomarkers
- RetinAI OCT Atlas
- Retinai Discovery
- Retinai Layer Segmentation
Catalogue references include 07640486840856, 7640486840016, 7640486840023, 7640486840030, 7640486840047, 7640486841167.
European nomenclature codes declared: Z12120192.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 7 |
| Country of registration | Switzerland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 7 |
|---|---|
| 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. Ikerian AG was not found in either the U.S. or the Canadian register.