Home›USA›Luminex Corporation

Luminex Corporation

USA · Madison

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel, Russia — 7 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

19listed device types

Class I 1Class II 18Class III 0

plus 18 registration records and 18 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

30registered devices

Class I 18Class II 12

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

28active device licences

Class II 28

42 including historic records

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

12active ARTG entries

IVD Class 1 12

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 States18 registration records, 18 510(k), 0 PMA, 2 excluded

Brazil30 confirmed, 0 excluded

Canada28 confirmed, 1 excluded

Manufacturer names merged into this page: Luminex Corporation · LUMINEX CORPORATION

FDA 510(k) clearances by year

12008

12013

12014

22015

42016

32017

12019

22024

22025

12026

FDA listed device types

showing 8 of 19

Human Metapneumovirus (Hmpv) Rna Assay System 1Parainfluenza Multiplex Nucleic Acid Assay 1Respiratory Virus Panel Nucleic Acid Assay System 1Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System 1Gram-Positive Bacteria And Their Resistance Markers 1Influenza A Virus Subtype Differentiation Nucleic Acid Assay 1Mycoplasma Pneumoniae Dna Assay System 1Real Time Nucleic Acid Amplification System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253722	LIAISON PLEX Gastrointestinal Flex Assay	2026-05-19
US	K243490	LIAISON PLEX Gram-Positive Blood Culture Assay	2025-06-06
US	K243013	LIAISON PLEX Gram-Negative Blood Culture Assay	2025-04-18
BR	81504790342	MAGPIX	Class II
BR	80391910015	Lifecodes Sheath Fluid PLUS	Class I
BR	80391910019	Instrumento FlexMap 3D	Class II
CA	86233	LUMINEX MAGPIX INSTRUMENT SYSTEM	Class II
CA	86234	LUMINEX 200 SYSTEM	Class II
CA	77113	MULTICODE-RTX BORDETELLA PERTUSSIS/PARAPERTUSSIS ASR	Class II

Luminex Corporation

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies