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SOPHYSA

France·FR-MF-000002870

Last updated September 17, 2026

Information

Country: France
Address: 5, GUY MOQUET, ORSAY, France
Website: www.sophysa.fr
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +33169351055
PRRC Contact: JULIE LOPEZ
EUDAMED SRN: FR-MF-000002870
FDA FEI Number: 3001587388
DUNS Number: 262951353

Catalogue (104)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
Pressio® 3 - Analog Blood Pressure Cable Mindray Beneview N1, N12, N15, N17, N19, N22	PSO-MPA08	EUDAMED	Class I	Active
Catheter Passer Disposable, 30 Cm + Sheath	TUD-30	EUDAMED	Class IIa	Active
Sophy® Mini Monopress. Valve Mp	SM1-M	EUDAMED	Class III	Active
Sophy® Sm1-M Valve / Burr Hole Reservoir	SM1B-M	EUDAMED	Class III	Active
Polaris® 24 Adjustable Valve / Antechamber	SPV24A-2010	EUDAMED	Class III	Active
Pressio® 3 - Analog Blood Pressure Cable Mindray Beneview T6 & Umec Series 8, 10, 12, 15	PSO-MPA06	EUDAMED	Class I	Active
Polaris® 24 Spv24 Kit Preattached / Bo19-10	SPV24-2010	EUDAMED	Class III	Active
Sophy® Mini Adjustable Valve/ 8 Press. 10-140	SM8-140	EUDAMED	Class III	Active
Pressio® 3 - Analog Blood Pressure Cable Mindray Passport 8, 12 & Epm 10, 12	PSO-MPA07	EUDAMED	Class I	Active
Catheter Passer Disposable, 45 Cm + Sheath	TUD-45	EUDAMED	Class IIa	Active
Sophy® Mini Sm3 Locating Instrument	SAK-LI-2	EUDAMEDFDA UDI	Class I	Active
TEMPERATURE PATIENT MONITOR CABLE PHILIPS (AGILENT) 2 pins	PSO-MCT-A	EUDAMEDFDA UDI	Class I	Active
Cath. Ventriculaire Coude Reserv. 6 Cm	PRO6	EUDAMEDFDA UDI	Class III	Active
PATIENT MONITOR CABLE NIHON KOHDEN 5 pins	PSO-MC08	EUDAMEDFDA UDI	Class I	Active
POLARIS® ADJUSTABLE VALVE 30-200 WITH SiphonX®	SPV-SX	EUDAMEDFDA UDI	Class III	Active
Cath. Ventriculaire Coude Reserv./Pect. 3 Cm	PLO3	EUDAMEDFDA UDI	Class III	Active
Sophy® Sm1-L Valve / Antechamber	SM1A-L	EUDAMED	Class III	Active
Pressio® Icp & Ict Monitoring Kit, Ventricular Tunneling	PSO-VTT	EUDAMEDFDA UDI	Class III	Active
PATIENT MONITOR CABLE GE DATEX OHMEDA 10 pins	PSO-MC04	EUDAMEDFDA UDI	Class I	Active
Cath. Ventriculaire Coude Reserv. 4 Cm	PRO4	EUDAMEDFDA UDI	Class III	Active
Kit Polaris® Spvb Preconnecte / Bo19-10	SPVB-2010	EUDAMEDFDA UDI	Class III	Active
Cath. Ventriculaire Coude Reserv. 7 Cm	PRO7	EUDAMEDFDA UDI	Class III	Active
Cath. Ventriculaire Coude Reserv./Pect.6 Cm	PLO6	EUDAMEDFDA UDI	Class III	Active
PRESSIO® 3 - PATIENT MONITOR CABLE PHILIPS, AGILENT, MINDRAY 12 pins	PSO-MCP01	EUDAMED	Class I	Active
Polaris® 24 Adjustable Valve	SPV24	EUDAMED	Class III	Active
Sophy® Sm1-H Kit Preattached/ Bo19-10	SM1-2010H	EUDAMED	Class III	Active
Cath. Ventriculaire Coude Reserv. 11 Cm	PRO11	EUDAMEDFDA UDI	Class III	Active
Cath. Ventriculaire Coude Reserv./Pect.7 Cm	PLO7	EUDAMEDFDA UDI	Class III	Active
Sophy® Sm1-M Valve / Antechamber	SM1A-M	EUDAMED	Class III	Active
External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters	K242974	FDA 510(k)	Class II	Active
Sophy Mini Monopressure Valve (SM1)	K250636	FDA 510(k)	Class II	Active
Pressio 3 Multi-parameter Neuromonitoring System	K252241	FDA 510(k)	Class II	Active
Catheter Ventriculaire Coude 6 Cm	BO60	EUDAMEDFDA UDI	Class III	Active
Sophy® Sm1-L Kit Preattached/ Bo19-10	SM1-2010L	EUDAMED	Class III	Active
PATIENT MONITOR CABLE GE SOLAR (MARQUETTE) 11 pins	PSO-MC05	EUDAMEDFDA UDI	Class I	Active
External Neurological Drainage System	DE-210	EUDAMED	Class IIa	Active
POLARIS® ADJUSTABLE VALVE 30-200 WITH BURR HOLE RESERVOIR AND SiphonX®	SPVB-SX	EUDAMEDFDA UDI	Class III	Active
Sophy® Mini Sm8 Locating Instrument	SAK-LI-1	EUDAMEDFDA UDI	Class I	Active
Cath. Ventriculaire Coude Reserv./Pect. 12 Cm	PLO12	EUDAMEDFDA UDI	Class III	Active
PATIENT MONITOR CABLE SPACELAB & MINDRAY 6 pins	PSO-MC03	EUDAMEDFDA UDI	Class I	Active
Cath. Ventriculaire Coude Reserv. 12 Cm	PRO12	EUDAMEDFDA UDI	Class III	Active
Sophy® Sm1a-H Kit Preattached / Bo19-10	SM1A-2010H	EUDAMED	Class III	Active
Catheter Ventriculaire Coude 8 Cm	BO80	EUDAMEDFDA UDI	Class III	Active
PRESSIO® 3 - ANALOG BLOOD PRESSURE CABLE PHILIPS Jack 3, 5mm	PSO-MPA01	EUDAMED	Class I	Active
Cath. Ventriculaire Coude Reserv. 9 Cm	PRO9	EUDAMEDFDA UDI	Class III	Active
Sophy® Sm1-H Valve / Burr Hole Reservoir	SM1B-H	EUDAMED	Class III	Active
Catheter Ventriculaire Coude 9 Cm	BO90	EUDAMEDFDA UDI	Class III	Active
Cath. Ventriculaire Coude Reserv./Pect. 10 Cm	PLO10	EUDAMEDFDA UDI	Class III	Active
SiphonX® GRAVITATIONAL ANTI-SIPHON DEVICE	SX-200	EUDAMEDFDA UDI	Class III	Active
External Lumbar Catheter With Introducer Guide	DE-109	EUDAMED	Class III	Active

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Sophysa SA US