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Immunotech SAS, a Beckman Coulter company

France · Marseille Cedex Bouches-Du-Rhone

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

19listed device types

Class I 6Class II 13Class III 0

plus 25 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

12registered devices

Class I 2Class II 10

19 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

42active device licences

Class II 42

211 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 States25 registration records, 0 510(k), 0 PMA, 5 excluded

Brazil12 confirmed, 6 excluded

Canada42 confirmed, 1 excluded

Manufacturer names merged into this page: Immunotech SAS, a Beckman Coulter company · IMMUNOTECH S.A.S., A BECKMAN COULTER COMPANY · IMMUNOTECH, A BECKMAN COULTER COMPANY

FDA listed device types

showing 8 of 19

Radioimmunoassay, Total Triiodothyronine 1Counter, Differential Cell 1Hepatitis A Test (Antibody And Igm Antibody) 1Test, Hiv Detection 1Flow Cytometric Reagents And Accessories. 1Calibrator, Secondary 1Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) 1Assayed Quality Control Material For Clinical Microbiology Assays 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	10033120985	Stem-Trol Control Cells	Class II
BR	10033120917	Access AMH	Class II
BR	10033120918	Access AMH CALIBRATORS	Class II
CA	62353	RIA 17A-HYDROXYPROGESTERONE	Class II
CA	72775	IRMA GH (HUMAN GROWTH HORMONE)	Class II
CA	82013	RIA ALDOSTERONE	Class II

Immunotech SAS, a Beckman Coulter company

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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