HomeJapanHoriba, Ltd.

Horiba, Ltd.

Japan · Kyoto Ky?To
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Taiwan, South Korea, Israel — 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
9listed device types
Class I 4Class II 5Class III 0
plus 5 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
5valid device licences
Class I 2Class II 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
IVD import 2
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 States5 registration records, 2 510(k), 0 PMA, 5 excluded
Brazil0 confirmed, 3 excluded
Canada0 confirmed, 3 excluded
Manufacturer names merged into this page: HORIBA LTD.

Company information

Country
Japan
City
Kyoto Ky?To

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Corporate Number
1130001011676
Registration status
Active
Registered capital
JPY 12,011,000,000

Business registration data from EDINET (Japan FSA), retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12002 · K022690
12019 · K183375

FDA listed device types

showing 8 of 9
Hexokinase, Glucose 1Electrode, Ion-Specific, Chloride 1Calibrator, Multi-Analyte Mixture 1Electrode, Ion Specific, Sodium 1Electrode, Ion Specific, Potassium 1General Purpose Reagent 1Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1Multi-Analyte Controls, All Kinds (Assayed) 1

Registration details (sample)

MarketIdentifierNameClass / date
USK183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode2019-02-12
USK022690PAROS CRP2002-12-23

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