SOPHYSA
FR-MF-000002870 · France · ORSAY
SOPHYSA is registered in the European database on medical devices as a manufacturer, with 132 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 94 |
|---|---|
| Class IIa | 37 |
| Class IIb | 1 |
Most frequent device types declared: B905S-20, BO15, BO60, BO90, DE-210.
Among these devices, 104 are declared sterile, 84 implantable, 1 active, 5 with a measuring function.
Devices declared under this manufacturer
- CATH. VENTRICULAIRE DROIT PEDIATRIQUE 1.3 x 2.2
- CATHETER EXTENSION CABLE
- CATHETER PERITONEAL ANTI-REFLUX
- CATHETER VENTRICULAIRE COUDE 6 CM
- CATHETER VENTRICULAIRE COUDE 9 CM
- DISPOSABLE HAND DRILL
- EXTERNAL NEUROLOGICAL DRAINAGE SYSTEM
- KIT DE RÉGLAGE-2 POLARIS®
- POLARIS® SPV-140 ADJUSTABLE VALVE / ANTECHAMBER
- PRESSIO® 2 ICP MONITOR
- SOPHY® READING INSTRUMENT
- SOPHY® SM1-H KIT PREATTACHED/ BO19-10
Showing 12 of 132 declared devices.
Catalogue references include B905S-20, BO60, DE-210, PAK2, PSO-4000, PSO-DR.
European nomenclature codes declared: N01038099, Z12039099, N0199, N01038002, Z12039001, A060399.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SOPHYSA (FR) · FDA 3001587388 |
| Devices in EUDAMED | 132 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 132 |
|---|---|
| Found in the U.S. device database | 87 |
| Share | 65.9 % |
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. SOPHYSA is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
40171 | supplemented | 2030-03-05 |