SONOSCANNER
FR-MF-000002220 · France · Ivry-sur-Seine
SONOSCANNER is registered in the European database on medical devices as a manufacturer, with 32 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 32 |
|---|
Most frequent device types declared: CURVILINEAR TRANSCUTANEOUS ULTRASOUND PROBES (CONVEX-ARRAY), ENDOCAVITORY ULTRASOUND PROBES, HANDHELD ULTRASOUND SCANNERS, LINEAR-ARRAY TRANSCUTANEOUS ULTRASOUND PROBES, MULTIDISCIPLINARY ULTRASOUND SCANNERS.
Among these devices, 32 are declared active.
Devices declared under this manufacturer
- ONDINA
- ORCHEO LITE CV
- PR18
- PR25
- PR28
- PR30
- PR50
- PR54
- PR58
- PR62
- PR90
- U LITE EXP
Showing 12 of 32 declared devices.
Catalogue references include ORCHEO LITE CV, PR18, PR25, PR28, PR58, PR90.
European nomenclature codes declared: Z110402010201, Z110402010101, Z11040106, Z11040103, Z110402010301, Z1104020201.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SONOSCANNER SARL (FR) · FDA 3011688715 |
| Devices in EUDAMED | 32 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 32 |
|---|---|
| Found in the U.S. device database | 17 |
| Share | 53.1 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SONOSCANNER SARL |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 1 |
| First licensed | 2026-07-14 |
Licence types: System (1).
Licensed under: HANDHELD ULTRASOUND SCANNERS.
North American profile: Both markets. SONOSCANNER is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1224430-1 | issued | 2029-04-17 |