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HITACHI HIGH-TECH CORP., NAKA DIVISION

Japan · Hitachinaka-Shi Ibaraki

✓ 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

13listed device types

Class I 5Class II 8Class III 0

plus 13 registration records and 0 510(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

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 States13 registration records, 0 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: HITACHI HIGH-TECH CORP., NAKA DIVISION · HITACHI HIGH- TECHNOLOGIES CORPORATION NAKA DIVISION

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

FDA listed device types

showing 8 of 13

Calculator/Data Processing Module, For Clinical Use 1Mass Spectrometer, Clinical Use 1Columns, Liquid Chromatography 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1Hemoglobin A1c Test System 1Dna Genetic Analyzer 1Hexokinase, Glucose 1

HITACHI HIGH-TECH CORP., NAKA DIVISION

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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