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Home›Japan›Hitachi Ltd. Healthcare Hitachi Works

Hitachi Ltd. Healthcare Hitachi Works

Japan · Hitachi
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Taiwan — 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
3listed device types
Class I 1Class II 2Class III 0
plus 3 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
1valid device licences
Class I 1
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 States3 registration records, 2 510(k), 0 PMA, 21 excluded
Brazil0 confirmed, 2 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: HITACHI HIGH-TECH CORP., Ome Works
Same-named companies — This database also contains companies with near-identical names: HITACHI HIGH-TECH CORP., Ome Works. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Japan
City
Hitachi

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 510(k) clearances by year

12017 · K171049
12018 · K181676

FDA listed device types

Automated Occult Blood Analyzer 1System, Test, Radioallergosorbent (Rast) Immunological 1Calculator/Data Processing Module, For Clinical Use 1

Registration details (sample)

MarketIdentifierNameClass / date
USK181676Mini Ridge Filter and auxiliary functions for PROBEAT-V2018-08-15
USK171049Real Time Image Gating System for Proton Beam Therapy Systems2017-12-26

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