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Biomerieux Sa, Inc.

France · Boxtel

✓ Record-verifiedregistrations found in 9 markets

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

69listed device types

Class I 40Class II 28Class III 0unclassified 1

plus 451 registration records and 264 510(k), 28 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

62registered devices

Class I 36Class II 26

101 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

66active device licences

Class II 30Class III 24Class IV 12

103 including historic records

TWTaiwanTFDA

115valid device licences

Class I 29Class II 85Class III 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

54active ARTG entries

IVD Class 1 12IVD Class 2 19IVD Class 3 18IVD Class 4 5

HKHong KongMDACS

3valid listings

IVD B 1IVD C 2

ILIsraelAMAR

12registrations

RURussiaRoszdravnadzor

44active registrations

Class 1 22Class 2a 18Class 2b 2Class 3 2

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 States451 registration records, 264 510(k), 28 PMA, 7 excluded

Brazil62 confirmed, 5 excluded

Canada66 confirmed, 1 excluded

Manufacturer names merged into this page: BIOMERIEUX SA · BIOMERIEUX, INC. · bioMerieux, Inc. · BioMerieux SA · BIOMERIEUX BV · BIOMERIEUX INC.

FDA 510(k) clearances by year

92007

92008

102009

72010

102011

122012

72013

32014

12015

72016

152017

32018

92019

52020

52021

92022

92023

42024

32025

42026

FDA listed device types

showing 8 of 69

Manual Antimicrobial Susceptibility Test Systems 1Antibody Igm,If, Cytomegalovirus Virus 1Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens 1Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates 1Reagent, Borrelia Serological Reagent 1Radioimmunoassay, Thyroid-Stimulating Hormone 1Antigen, Inflammatory Response Marker, Sepsis 1Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260160	VITEK REVEAL GN AST Assay and VITEK REVEAL AST System	2026-07-08
US	K260447	ETEST Gepotidacin (GEP) (0.016-256 µg/mL)	2026-04-21
US	K260282	VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance	2026-04-15
BR	10158120359	UREIA-ARGININA LYO 2	Class I
BR	10158120258	VIDAS PROGESTERONA (VIDAS PROGESTERONE)	Class II
BR	10158120118	VIDAS CORTISOL S	Class II
CA	2691	LIATEK HCV III	Class IV
CA	2830	VIRONOSTIKA HIV MICROELISA SYSTEM (DONOR SCREENING)	Class IV
CA	2870	MONOSTICON DRI-DOT	Class II

Biomerieux Sa, 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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