Optimums Innovations Limited trading as Proworks
UK-MF-000056184 · United Kingdom · Stockton-On-Tees
Optimums Innovations Limited trading as Proworks is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 14 |
|---|
Most frequent device types declared: Baby Pink, Yellow, White, Skin, Red, Purple, Orange, Hot Pink, Green L.
Authorised representative in the Union: SUNGO Europe B.V..
Catalogue references include Baby Pink, Black, Dark Blue, Green Leaf, Hot Pink, Light Blue.
European nomenclature codes declared: M030402030102.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 14 |
| 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 | 14 |
|---|---|
| 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. Optimums Innovations Limited trading as Proworks was not found in either the U.S. or the Canadian register.