siHealth Ltd.
GB-MF-000034129 · United Kingdom · Didcot
siHealth Ltd. is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 6 |
|---|
Most frequent device types declared: SmartPDT, Sun4Health.
Authorised representative in the Union: siHealth Photonics S.r.l..
Devices declared under this manufacturer
- SmartPDT-D
- SmartPDT-P Android
- SmartPDT-P iOS
- Sun4Health App Android
- Sun4Health App iOS
- Sun4Health Web Portal
Catalogue references include SmartPDT-D, SmartPDT-P Android, SmartPDT-P iOS, Sun4Health App Android, Sun4Health App iOS, Sun4Health Web Portal.
European nomenclature codes declared: Z12040192, Z12040292.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 6 |
| 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 | 6 |
|---|---|
| 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. siHealth Ltd. was not found in either the U.S. or the Canadian register.