SOPRO
FR-MF-000000833 · France · La Ciotat
SOPRO is registered in the European database on medical devices as a manufacturer, with 71 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 71 |
|---|
Most frequent device types declared: 700342L, 990215, 990314, C20, SOPIX SERIES.
Among these devices, 31 are declared active.
Devices declared under this manufacturer
- 54.0950.00 - C20 CAMERA HANDPIECE
- C50 - INTRAORAL CAMERA
- C50 INTRAORAL CAMERA US
- C50 INTRAORAL CAMERA US DAYL
- C50TIPS
- DOCK SOPIX2 PLUG-IN
- PSPIX2
- PSPIX2 Bag & Cover
- PSPIX2 Intraoral Imaging Plate
- PSPIX2 Intraoral Imaging plate
- PSPIX2 Intraoral Start up kit
- Protective Bag
Showing 12 of 71 declared devices.
Catalogue references include 700339L, 700546, 700548, 990217, 990248, 990265.
European nomenclature codes declared: Z1103040102, Q010599, Z1103040101, Z11039010, Z110601, Q0199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SOPRO (FR) · FDA 9615782 |
| Devices in EUDAMED | 71 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 71 |
|---|---|
| Found in the U.S. device database | 5 |
| Share | 7.0 % |
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. SOPRO is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
39219 | restricted | 2027-12-26 |