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ROCHE MOLECULAR SYSTEMS, INC.

USA · Branchburg

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

52listed device types

Class I 10Class II 33Class III 4unclassified 5

plus 143 registration records and 53 510(k), 655 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

37registered devices

Class I 27Class II 10

94 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

16active device licences

Class III 8Class IV 8

88 including historic records

TWTaiwanTFDA

49valid device licences

Class I 9Class II 20Class III 20

SGSingaporeHSA SMDR

29device registrations

CLASS B 1CLASS C 18CLASS D 10

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

IVD import 4

AUAustraliaTGA ARTG

27active ARTG entries

IVD Class 1 3IVD Class 2 3IVD Class 3 12IVD Class 4 9

HKHong KongMDACS

26valid listings

IVD B 3IVD C 18IVD D 5

ILIsraelAMAR

67registrations

RURussiaRoszdravnadzor

43active registrations

Class 1 4Class 2a 19Class 2b 1Class 3 19

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 States143 registration records, 53 510(k), 655 PMA, 29 excluded

Brazil37 confirmed, 9 excluded

Canada16 confirmed, 6 excluded

Manufacturer names merged into this page: ROCHE MOLECULAR SYSTEMS, INC. · ROCHE MOLECULAR SYSTEMS, INC · ROCHE MOLECULAR SYSTEMS · ROCHE MOLECULAR SYSTEMS INC.

FDA 510(k) clearances by year

21997

11998

31999

12002

12004

12005

12010

12012

12013

22014

22015

22017

22018

32019

32020

52021

32022

32023

112025

42026

FDA listed device types

showing 8 of 52

Bordetella Pertussis Dna Assay System 1Device To Detect Antibodies To Hepatitis D Virus 1Cytomegalovirus (Cmv) Dna Quantitative Assay 1Respiratory Virus Panel Nucleic Acid Assay System 1Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna 1Automated Radiological Image Processing Software 1Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings 1Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260021	cobas® BV/CV	2026-07-16
US	K260917	cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems	2026-07-08
US	K253759	cobas liat CT/NG/MG nucleic acid test	2026-05-15
BR	10287411342	Cobas Liat System	Class II
BR	10287411598	MagNA Pure 24 Total NA Isolation Kit	Class I
BR	10287411155	MagNA Pure 96 External Lysis Buffer	Class I
CA	62369	QUALITATIVE HIV-1 TEST KITS (DONOR SCREENING/CADAVERIC TESTING)	Class IV
CA	62392	NAT CONTROLS	Class IV
CA	71111	CHLAMYDIA NAT TEST KITS	Class III