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BECKMAN COULTER BIOTECHNOLOGY (SUZHOU) CO., LTD.

China · Suzhou Jiangsu

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Australia, Israel, Russia — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

242listed device types

Class I 81Class II 156Class III 4unclassified 1

plus 797 registration records and 290 510(k), 183 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

385registered devices

Class I 129Class II 256

518 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

170active device licences

Class II 146Class III 21Class IV 3

454 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IVD Class 1 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States797 registration records, 290 510(k), 183 PMA, 3 excluded

Brazil385 confirmed, 0 excluded

Canada170 confirmed, 0 excluded

Manufacturer names merged into this page: BECKMAN COULTER, INC. · Beckman Coulter Ireland Inc · BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. · Beckman Coulter India Private Limited · HYBRITECH INCORPORATED A WHOLLY OWNED SUBSIDIARY OF BECKMAN COULTER 1 · BECKMAN COULTER INC.

Same-named companies — This database also contains companies with near-identical names: BECKMAN COULTER, INC., BECKMAN COULTER BIOMEDICAL LIMITED, BECKMAN COULTER DO BRASIL COMÉRCIO E IMPORTAÇÃO DE PRODUTOS DE LABORATÓRIO LTDA, Beckman Coulter Distribution B.V.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

82007

62008

122009

42010

82011

22012

82013

102014

32015

42016

92017

22018

102019

62020

22021

42022

162023

192024

102025

42026

FDA listed device types

showing 8 of 242

Counter, Differential Cell 1Igm, Antigen, Antiserum, Control 1Enzyme Immunoassay, Benzodiazepine 1Cardiac C-Reactive Protein, Antigen, Antiserum, And Control 1Electrode, Ion Specific, Urea Nitrogen 1Starch-Dye Bound Polymer, Amylase 1Calibrator For Hemoglobin And Hematocrit Measurement 1System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252169	Access BNP II	2026-03-24
US	K254059	Access anti-HBc IgM	2026-03-13
US	K253687	Access anti-HBc Total	2026-02-19
BR	10003310053	COULTER RETIC-PREP REAGENT KIT	Class I
BR	10003310313	IMMAGE Haptoglobin Reagent	Class II
BR	10033121073	Família de Reagente e Calibradores Access Progesterone II	Class II
CA	3042	ACT SERIES HEMATOLOGY ANALYZER	Class II
CA	5392	CZE 2000 ELECTROPHORESIS SYSTEM	Class II
CA	5873	CREATININE ANALYZER 2	Class II

BECKMAN COULTER BIOTECHNOLOGY (SUZHOU) CO., LTD.

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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