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HORIBA INSTRUMENTS BRASIL LTDA

Brazil

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

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

Brazil80 confirmed, 1 excluded

Canada0 confirmed, 3 excluded

Manufacturer names merged into this page: HORIBA INSTRUMENTS INCORPORATED · 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 BRASIL LTDA

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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