Out of Site Ltd
UK-MF-000042912 · United Kingdom · Great Dunmow
Out of Site Ltd is registered in the European database on medical devices as a manufacturer, with 308 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 308 |
|---|
Authorised representative in the Union: SigmaTech Nordic ApS.
Devices declared under this manufacturer
- eye-spec
Showing 12 of 308 declared devices.
Catalogue references include aa-gol150, kreu-tor300, look-gol250, poc-blaXL175, poc-pin250, pod-gra200.
European nomenclature codes declared: Q0210030201.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 308 |
| Country of registration | United Kingdom |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 308 |
|---|---|
| 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. Out of Site Ltd was not found in either the U.S. or the Canadian register.