HomeJapanMitsubishi Heavy Industries, Ltd.

Mitsubishi Heavy Industries, Ltd.

Japan · Hiroshima-Shi
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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
3510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 3 510(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
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 States0 registration records, 3 510(k), 0 PMA, 1 excluded

Company information

Country
Japan
City
Hiroshima-Shi

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

Legal name
Mitsubishi Heavy Industries,Ltd.
Corporate Number
8010401050387
Registration status
Active
Registered capital
JPY 265,608,000,000

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

12007 · K072047
12012 · K122450
12015 · K152867

Registration details (sample)

MarketIdentifierNameClass / date
USK152867MHI-TM2000 Linear Accelerator System, VERO, Imavis2015-10-21
USK122450MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS2012-10-03
USK072047MHI-TM2000 LINEAR ACCELERATOR SYSTEM2007-08-29

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