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Medex, Inc.

France · Saint-Priest

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, South Korea, Australia, Hong Kong, Israel — 9 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

2listed device types

Class I 0Class II 2Class III 0

plus 2 registration records and 50 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class II 8

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

4 including historic records

TWTaiwanTFDA

6valid device licences

Class II 6

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

8active ARTG entries

IIa 3IIb 1Class Is (sterile) 4

HKHong KongMDACS

4valid listings

Class II 4

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

pendingnot queried

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 States2 registration records, 50 510(k), 0 PMA, 7 excluded

Brazil8 confirmed, 2 excluded

Saudi Arabia2 confirmed, 0 excluded

Canada1 confirmed, 1 excluded

Manufacturer names merged into this page: MEDEX

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242255	Qitexio® 4-Way Stopcock (QIT014)	2025-04-29
US	K203738	Qitexio	2022-03-14
US	K042432	PHARMGUARD TOOLBOX, MODEL G6000782	2005-01-04
BR	10061400028	SECUFILL	Class II
BR	80136719009	Manyfill® 24h	Class II
BR	80136719010	SECUFILL	Class II
SA	ME0000015141SFDAA00006	Contrast&Care	—
SA	ME0000000624SFDAA00001	Injection Data Collector	—
CA	103864	VECTORIO	Class II

Medex, Inc.

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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