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Sysmex Corporation of America

USA · Lincolnshire

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

32listed device types

Class I 18Class II 14Class III 0

plus 88 registration records and 34 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

16active device licences

Class II 14Class III 2

20 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States88 registration records, 34 510(k), 0 PMA, 11 excluded

Brazil0 confirmed, 3 excluded

Canada16 confirmed, 2 excluded

Manufacturer names merged into this page: Sysmex America, Inc. · Sysmex America, Inc. - Vernon Hills · SYSMEX REAGENTS AMERICA, INC. · SYSMEX AMERICA, INC. · SYSMEX REAGENTS AMERICA

FDA 510(k) clearances by year

22002

12003

22004

32005

32006

22007

32008

12009

12010

12012

12014

12015

22016

12017

22018

12019

12022

12023

32025

12026

FDA listed device types

showing 8 of 32

Counter, Differential Cell 1Calibrator, Secondary 1Counter, Urine Particle 1System, Multipurpose For In Vitro Coagulation Studies 1Device, Automated Cell-Locating 1Calibrator For Red-Cell And White-Cell Counting 1Calibrator, Surrogate 1Instrument, Coagulation, Automated 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253212	XR-Series (XR-10, XR-20) Automated Hematology Analyzers	2026-05-27
US	K251371	Sysmex XR-Series (XR-20) Automated Hematology Analyzer	2025-06-25
US	K250943	Sysmex XR-Series (XR-10) Automated Hematology Analyzer	2025-06-25
CA	1803	HEMATOLOGY ANALYZER	Class II
CA	3769	SULFOLYSER	Class II
CA	4685	R 3000 AUTO RETICULOCYTE ANALYZER	Class II

Sysmex Corporation of America

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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