Optik Sutter e.U.
AT-MF-000052724 · Austria · Dornbirn
Optik Sutter e.U. is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 13 |
|---|
Devices declared under this manufacturer
- Brillenwerk von Optik Sutter
Showing 12 of 13 declared devices.
Catalogue references include BW01-M-46, BW01-M-47, BW01-M-50, BW01-M-51, BW01-M-52, BW01-M-54.
European nomenclature codes declared: Q02100202.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 13 |
| Country of registration | Austria |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 13 |
|---|---|
| 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. Optik Sutter e.U. was not found in either the U.S. or the Canadian register.