HomeJapanHAMAMATSU PHOTONICS ELECTRON TUBE DIVISION

HAMAMATSU PHOTONICS ELECTRON TUBE DIVISION

Japan · Iwata City Shizuoka
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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
6listed device types
Class I 0Class II 6Class III 0
plus 8 registration records and 10 510(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
1active device licences
Class II 1
4 including historic records
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 States8 registration records, 10 510(k), 0 PMA
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: HAMAMATSU PHOTONICS K.K., SYSTEMS DIVISION · HAMAMATSU PHOTONICS ELECTRON TUBE DIVISION · HAMAMATSU PHOTONICS K.K. SYSTEMS DIVISION (JOKO FACTORY)
Same-named companies — This database also contains companies with near-identical names: Hamamatsu Photonics K.K., HAMAMATSU PHOTONICS K.K., SYSTEMS DIVISION. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Japan
City
Iwata City Shizuoka

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
HAMAMATSU PHOTONICS K.K.
Corporate Number
2080401004193
Registration status
Active
Registered capital
JPY 34,964,000,000

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

11989
11998
12012
12014
12015
12016
12022
12023
22026

FDA listed device types

Whole Slide Imaging System 1Devices Detecting Influenza A, B, And C Virus Antigens 1Oximeter, Tissue Saturation 1Confocal Optical Imaging 1Oximeter 1System, X-Ray, Angiographic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK260964NanoZoomer S540MD Slide Scanner System2026-07-22
USK253606NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system2026-07-15
USK233027NanoZoomer S360MD Slide scanner system2023-12-22
CA94607PDE-NEOIIClass II

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