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SYSMEX CORPORATION

Japan · Kobe

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, 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

21listed device types

Class I 12Class II 9Class III 0

plus 39 registration records and 18 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

66registered devices

Class I 30Class II 36

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

3active device licences

Class II 2Class III 1

36 including historic records

TWTaiwanTFDA

14valid device licences

Class I 2Class II 12

SGSingaporeHSA SMDR

22device registrations

CLASS B 17CLASS C 3CLASS D 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

16active ARTG entries

IVD Class 1 7IVD Class 2 9

HKHong KongMDACS

4valid listings

IVD B 4

ILIsraelAMAR

53registrations

RURussiaRoszdravnadzor

44active registrations

Class 1 3Class 2a 41

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 States39 registration records, 18 510(k), 0 PMA, 15 excluded

Brazil66 confirmed, 2 excluded

Canada3 confirmed, 4 excluded

Manufacturer names merged into this page: SYSMEX CORPORATION

Business registration

Corporate Number: 9140001009530
Registration status: Active
Registered capital: JPY 14,887,000,000

Business registration data from EDINET (Japan FSA), retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

51979

51995

11996

31997

21998

11999

12001

FDA listed device types

showing 8 of 21

Diluent, Blood Cell 1Urinalysis Controls (Assayed And Unassayed) 1Stain, Reticulocyte 1Container, Specimen, Non-Sterile 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1Multi-Analyte Controls, All Kinds (Assayed) 1Slide Stainer, Automated 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K012372	SYSMEX UF-50	2001-09-28
US	K992875	SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER	1999-11-09
US	K981950	SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500	1998-11-03
BR	80015490001	CELLSHEATH	Class I
BR	80015490006	STROMATOLYSER 4 DL	Class I
BR	80015490004	STROMATOLYSER 4 DS	Class I
CA	13666	BLOOD COAG ANALYSER CA6000	Class III
CA	87020	UX-2000 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM	Class II
CA	101779	SYSMEX UC-3500 FULLY AUTOMATED URINE CHEMISTRY TEST SYSTEM	Class II

SYSMEX CORPORATION

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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