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HORIBA INSTRUMENTS INCORPORATED

USA · Canton

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Singapore, Israel — 5 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

99listed device types

Class I 33Class II 65Class III 0unclassified 1

plus 150 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

80registered devices

Class I 20Class II 60

95 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

26 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States150 registration records, 5 510(k), 0 PMA, 5 excluded

Brazil80 confirmed, 1 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: HORIBA INSTRUMENTS INCORPORATED · HORIBA INSTRUMENTS INC ADBA: HORIBA MEDICAL, POINTE, POINTE SCIENTIFIC, AND CLINTOX BRANDS · HORIBA INSTRUMENTS BRASIL LTDA

FDA 510(k) clearances by year

21984 · K841424

31985 · K853405

FDA listed device types

showing 8 of 99

Colorimeter, Photometer, Spectrophotometer For Clinical Use 1Phosphomolybdate (Colorimetric), Inorganic Phosphorus 1Ferrozine (Colorimetric) Iron Binding Capacity 1Controls For Blood-Gases, (Assayed And Unassayed) 1Drug Mixture Control Materials 1Ldl & Vldl Precipitation, Hdl 1Enzymatic Method, Ammonia 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K853405	ELECTROLYTE ANALYZER SERA-252	1985-12-04
US	K853356	SERA-210 ELECTROLYTE ANALYZER	1985-09-03
US	K844806	MODIFY ELECTROLYTE ANALYZER MODEL SERA-210	1985-01-08
BR	10347320004	ABX CLEANER	Class I
BR	10347320008	ABX MINILYSE LMG	Class I
BR	10347320011	ABX DILUENT	Class I

HORIBA INSTRUMENTS INCORPORATED

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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