Stereotest Limited
UK-MF-000048319 · United Kingdom · Peterborough
Stereotest 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: FD2, FNS1, FNS3P, FPS-1P, FPS2P.
Authorised representative in the Union: Comply Express Lda.
Devices declared under this manufacturer
- The Frisby Davis Distance Stereotest
- The Frisby Near Stereotest Replacement Box
- The Frisby Screener Pocket Stereotest (1 Plate)
- The Frisby Screener Pocket Stereotest (2 Plates)
- he Frisby Near Stereotest (3 Plates)
Catalogue references include FD2, FNS-1, FNS-3P, FPS-1P, FPS-2P.
European nomenclature codes declared: Q0299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 5 |
| 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 | 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. Stereotest Limited was not found in either the U.S. or the Canadian register.