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Hitachi High-Tech Corp.

Japan · Kashiwa-Shi

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Taiwan, 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

17listed device types

Class I 5Class II 12Class III 0

plus 37 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

3valid device licences

Class I 1Class II 2

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 States37 registration records, 1 510(k), 0 PMA, 17 excluded

Brazil1 confirmed, 1 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: HITACHI HIGH-TECH CORP., KASHIWANOHA · HITACHI HIGH-TECH CORP., NAKA DIVISION · Hitachi High-Tech Corp., Omuta Center · HITACHI HIGH-TECH CORP., Musashimurayama Center · HITACHI HIGH- TECHNOLOGIES CORPORATION NAKA DIVISION

Same-named companies — This database also contains companies with near-identical names: HITACHI HIGH-TECH AMERICA, INC. RADIATION THERAPY DIVISION. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12026 · K260174

FDA listed device types

showing 8 of 17

Hemoglobin A1c Test System 1Automated Occult Blood Analyzer 1Dna Genetic Analyzer 1Hexokinase, Glucose 1System, Test, Radioallergosorbent (Rast) Immunological 1Enzyme Immunoassay, Methadone 1Electrode, Ion-Specific, Chloride 1Accelerator, Linear, Medical 1

Market	Identifier	Name	Class / date
US	K260174	PROBEAT-CR	2026-06-11
BR	10358940021	ANALISADOR GENÉTICO 3500 DX	Class II

Hitachi High-Tech Corp.

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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