12 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Country: France
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SOPHYSA
Manufacturer
🇫🇷 France·2 Basic UDI-DIs·2 Devices
SOPHYSA
FDA registration
SOPHYSA·4 products·🇫🇷 France
SOPHYSA
FDA registration
SOPHYSA·4 products·🇫🇷 France
PRESSIO® MRI SUPPORT
Device
EU MDR
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Eu Md Class 1
·SOPHYSA·On the market·21 countries
KIT DE RÉGLAGE-2 POLARIS®
Device
EU MDR
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Eu Md Class 1
·SOPHYSA·On the market·11 countries
PRESSIO MRI SUPPORT
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·SOPHYSA·1 device
Polaris® Valve Adjustment kit-2
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·SOPHYSA·1 device
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
FDA Enforcement
Class II
·Ongoing·Sophysa·January 14, 2026
SOPHYSA
Importer
🇫🇷 France·1 Manufacturer
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VT
FDA Enforcement
Class II
·Ongoing·Sophysa S.A.·May 22, 2024
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VTT
FDA Enforcement
Class II
·Ongoing·Sophysa S.A.·May 22, 2024
SOPHYSA
System producer
🇫🇷 France