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HAMAMATSU PHOTONICS K.K., SYSTEMS DIVISION

Japan · Hamamatsu City Shizuoka

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Israel — 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

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

4registrations

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 ELECTRON TUBE DIVISION, Hamamatsu Photonics K.K.. Company name alone cannot separate their registrations, so the figures below may include either.

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)

Market	Identifier	Name	Class / date
US	K260964	NanoZoomer S540MD Slide Scanner System	2026-07-22
US	K253606	NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system	2026-07-15
US	K233027	NanoZoomer S360MD Slide scanner system	2023-12-22
CA	94607	PDE-NEOII	Class II

HAMAMATSU PHOTONICS K.K., SYSTEMS DIVISION

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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