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Sophysa SA

France · Orsay Cedex Essonne

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Singapore, Australia, Israel, Russia — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 1Class II 3Class III 0

plus 28 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 4Class II 3

33 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

2device registrations

CLASS D 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

21active ARTG entries

Class I 5Class III 14IIa 1IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

3active registrations

Class 3 3

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States28 registration records, 13 510(k), 0 PMA

Brazil7 confirmed, 0 excluded

Manufacturer names merged into this page: SOPHYSA

FDA 510(k) clearances by year

12000

12002

22004

12007

12009

12010

12015

12017

12023

22025

12026

FDA listed device types

Lumbar Drainage Catheter Kit 1Device, Monitoring, Intracranial Pressure 1Shunt, Central Nervous System And Components 1Instrument, Shunt System Implantation 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252241	Pressio 3 Multi-parameter Neuromonitoring System	2026-04-10
US	K250636	Sophy Mini Monopressure Valve (SM1)	2025-11-28
US	K242974	External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters	2025-06-20
BR	80003890134	Suporte IRM Pressio®	Class I
BR	80003890037	BOLSA PARA DRENAGEM NEUROLOGICA EXTERNA SOPHYSA	Class II
BR	80003890041	KIT DE AJUSTE SOPHYSA	Class I

Sophysa SA

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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