Scope Ophthalmics Limited
IE-MF-000037510 · Ireland · Dublin
Scope Ophthalmics Limited is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 5 |
|---|
Most frequent device types declared: FRMX2, KK-CH-III180.
Among these devices, 1 are declared active.
Devices declared under this manufacturer
- Fusion Allergy
- Optase Cooling Mask
- Optase® Moist Heat Mask
Catalogue references include FRFUSION-COOL MASK, FRMX2, FROPTASE-COOL MASK, FROPTASE-HMPro, FROPTASE-MHM.
European nomenclature codes declared: M9001, Q0299, Z12120199.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 5 |
| Country of registration | Ireland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| 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. Scope Ophthalmics Limited was not found in either the U.S. or the Canadian register.