Fortuna Healthcare Limited
UK-MF-000048072 · United Kingdom · Enfield
Fortuna Healthcare Limited is registered in the European database on medical devices as a manufacturer, with 369 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 369 |
|---|
Most frequent device types declared: EX110A, FT01PS, FT1102, FT14AS, FT167S.
Authorised representative in the Union: Fortuna Healthcare (Ireland) Limited.
Devices declared under this manufacturer
- FORTUNA
- OXFORD READING GLASSES BROWN 2.50
- READING GLASSES / GUNMETAL FRAME
- READING GLASSES BOSTON GREY 3.50
- READING GLASSES BOSTON NAVY 3.00
- READING GLASSES DALLAS 1.50
- READING GLASSES DENVER 2.00
- READING GLASSES HOUSTON 3.00
- READING GLASSES HOUSTON 3.50
- READING GLASSES MEMPHIS 4.00
- READING GLASSES MIAMI 1.50
- READING GLASSES MIAMI 3.00
Showing 12 of 369 declared devices.
Catalogue references include EX1000S, FT016, FT1468, FT25DENVER2.00, FT25HOUSTON3.50, FT25MEMPHIS4.00.
European nomenclature codes declared: Q0210030103, Y061209, Y06120601, M050202, Y060612, Y061203.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 369 |
| 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 | 369 |
|---|---|
| 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. Fortuna Healthcare Limited was not found in either the U.S. or the Canadian register.