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IMMUCOR, INC.

USA · Norcross

✓ 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

15listed device types

Class I 5Class II 10Class III 0

plus 60 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

21registered devices

Class I 19Class II 2

45 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

37active device licences

Class II 3Class III 33Class IV 1

74 including historic records

TWTaiwanTFDA

61valid device licences

Class I 6Class II 49Class III 6

SGSingaporeHSA SMDR

24device registrations

CLASS C 11CLASS D 13

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

13active ARTG entries

IVD Class 1 1IVD Class 2 2IVD Class 3 7IVD Class 4 3

HKHong KongMDACS

15valid listings

IVD C 8IVD D 7

ILIsraelAMAR

11registrations

RURussiaRoszdravnadzor

3active registrations

Class 1 1Class 2a 2

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 States60 registration records, 3 510(k), 0 PMA, 2 excluded

Brazil21 confirmed, 2 excluded

Canada37 confirmed, 1 excluded

Manufacturer names merged into this page: IMMUCOR, INC. · IMMUCOR INC. · IMMUCOR INC · IMMUCOR, INC

FDA 510(k) clearances by year

11991 · K910003

12019 · K183571

12021 · K203612

FDA listed device types

showing 8 of 15

Blood Establishment Computer Software And Accessories 1Antigen, Iha, Cytomegalovirus 1Test, Donor, Cmv 1Media, Potentiating For In Vitro Diagnostic Use 1Test, Screening, For D Positive Fetal Rbc'S 1System, Test, Automated Blood Grouping And Antibody 1Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use 1Lectins And Protectins 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K203612	Capture-CMV	2021-03-22
US	K183571	Capture-CMV	2019-02-04
US	K910003	CYTOMEGALOVIRUS ANTIBODY SCREEN	1991-03-20
BR	10077090104	ANALISADOR DE IMUNOHEMATOLOGIA GALILEO ECHO	Class II
BR	10077090107	GALILEO NEO	Class II
BR	10077090116	DILUENTE ECHO	Class I
CA	1092	ANTI-HUMAN GLOBULIN	Class III
CA	10247	FETAL BLEED SCREENING KIT	Class II
CA	13068	BLOOD GROUPING REAGENT BY INDIRECT ANTIGLOBULIN TEST	Class III