Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006240422

FEI Number

3001587388

Entity Name

SOPHYSA

City/State/Country

BESANCON Doubs, FR

Establishment Address

Rue Sophie Germain, Technopole TEMIS, BESANCON Doubs 25000, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SOPHYSA (Owner Number: 10023919)

Owner / Operator Contact Address

5 RUE GUY MOQUET, ORSAY, FR-91 91400, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K853365

PMA Number

N/A

All Registered Proprietary Names

External Drainage catheters PRESSIO SOPHYSA SHUNT SOPHYSA SHUNT SOPHYSA SHUNT SOPHY Pressio 2 ICP monitoring system POLARIS Valves electronic Reading Instrument SOPHYSA ACCESSORIES POLARIS Adjustable Pressure Valve System POLARIS Adjustable Pressure Valve Siphon X Gravitational Anti-siphon SOPHYSA SHUNT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PVO	Lumbar Drainage Catheter Kit	Neurology	Class 2	882.5550	2025-07-16
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2025-07-16
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2007-12-21
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2010-05-25
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2010-05-25
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2010-05-25
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2007-12-21
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2017-07-24
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2023-04-04
GYK	Instrument, Shunt System Implantation	Neurology	Class 1	882.4545	2010-05-25
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2020-11-25
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2010-02-01
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2010-05-25

Official Correspondent

Philippe NEGRE

US Agent Details

Paul GORDON Business: Sophysa USA Inc. Email: paul.gordon@sophysa.us Phone: (219) 6637711

Related Public Records

Same Entity

SOPHYSA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3001587388	SOPHYSA	ORSAY, CEDEX Essonne, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K981246	Integra Neurocare, LLC	BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)	1999-05-26
K020558	Integra Neurosciences	LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE	2002-03-21

Similar Registrations

Registration Number	Establishment Name	Location
9616088	Convertors de Mexico S. de R.L. de C.V	CD.JUAREZ Chihuahua, MX
3007329020	Cardinal Health 200, LLC	El Paso, TX, US
3009888344	Isomedix Operations Inc	El Paso, TX, US
3004111573	Sterigenics US LLC	Grand Prairie, TX, US
1643817	ISOMEDIX OPERATIONS INC	EL PASO, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006240422. Last updated year: 2026. Please use registration number 3006240422 when referencing this establishment in official correspondence.