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HEMAGEN DIAGNOSTICS, INC.

USA · Waltham

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Singapore — 4 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

43listed device types

Class I 14Class II 28Class III 0unclassified 1

plus 73 registration records and 52 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

30registered devices

Class II 30

31 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

2active device licences

Class II 2

37 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

5device registrations

CLASS B 2CLASS C 3

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 States73 registration records, 52 510(k), 0 PMA

Brazil30 confirmed, 1 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: HEMAGEN DIAGNOSTICS, INC. · HEMAGEN DIAGNOSTICS INC. · HEMAGEN DIAGNÓSTICS · HEMAGEN DIAGNOSTICS INC

FDA 510(k) clearances by year

21986

11989

21990

31991

31992

11993

31994

91995

31996

71997

31999

12000

52001

52002

12003

32004

FDA listed device types

showing 8 of 43

Anti-Human Globulin, Fta-Abs Test 1Calibrator, Secondary 1Calibrator, Primary 1System, Test, Rheumatoid Factor 1Catalytic Methods, Amylase 1System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) 1Extractable Antinuclear Antibody, Antigen And Control 1Enzymatic, Carbon-Dioxide 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K041051	RAICHEM BUN RATE REAGENT (LIQUID)	2004-06-30
US	K041052	RAICHEM GLUCOSE UV (LIQUID)	2004-06-30
US	K041009	RAICHEM CALCIUM (OCPC) LIQUID REAGENT	2004-06-25
BR	10280220165	ENA SCREENING 4 HEMAGLUTINACAO	Class II
BR	10280220156	RF (FATOR REUMATOIDE) HEMAGLUTINACAO	Class II
BR	10280220153	DNA HEMAGLUTINACAO	Class II
CA	4813	HEMAGEN IGA CALIBRATOR	Class II
CA	4783	HEMAGEN ANTI-CARDIOLIPIN SCREEN KIT	Class II

HEMAGEN DIAGNOSTICS, INC.

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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