Sunoptic International Ltd
GB-MF-000009257 · United Kingdom · Harrow
Sunoptic International Ltd is registered in the European database on medical devices as a manufacturer, with 1 064 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 1 064 |
|---|
Most frequent device types declared: Frames CP mix fullrim, Frames CP mix fullrim sun, Frames Metal Mix, Frames TR90 mix fullrim, Frames acetate mix fullrim.
Among these devices, 388 are declared active.
Authorised representative in the Union: Sunoptic Europe.
Devices declared under this manufacturer
- 852B
- 852D
- 873D
- 885E
- 888E
- AC367
- M297E
- MK48E
- MK49C
- MM580D
- MR11S1.00
- MR15A1.00
Showing 12 of 1 064 declared devices.
Catalogue references include 852D, 888E, AC367, M297E, MK48E, MM580D.
European nomenclature codes declared: Q0210030101, Q02100201, Q0210030199, Q0210030102, Q02100299, Q0210030299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 1 064 |
| 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 | 1 064 |
|---|---|
| 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. Sunoptic International Ltd was not found in either the U.S. or the Canadian register.