SiVIEW
FR-MF-000007298 · France · Paris
SiVIEW is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 6 |
|---|
Most frequent device types declared: Software indicated to automate the subjective refraction eye exam.
Among these devices, 6 are declared active.
Devices declared under this manufacturer
- SiVIEW BOX V2
- SiVIEW CONSOLE
- SiVIEW Dongle DA15-232-04)
- SiVIEW Dongle DA15-485-03
- SiVIEW Dongle DE9-232HFC-02
- SiVIEW EXAM
Catalogue references include BX2, DG-002, DG-003, DG-004, SiVIEW EXAM, VC.
European nomenclature codes declared: Q0299, Z12129082.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SIVIEW SAS (FR) · FDA 3022375836 |
| Devices in EUDAMED | 6 |
| Country of registration | France |
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: United States only. SiVIEW is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
283/MDR | issued | 2030-04-29 |