HomeJapanHITACHI HIGH- TECHNOLOGIES CORPORATION NAKA DIVISION

HITACHI HIGH- TECHNOLOGIES CORPORATION NAKA DIVISION

Japan
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, South Korea — 3 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
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
IVD import 1
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-TECH CORP., NAKA DIVISION. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Japan

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.

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

Registration details (sample)

MarketIdentifierNameClass / date
BR10358940021ANALISADOR GENÉTICO 3500 DXClass II

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