Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005586126

FEI Number

3005586126

Entity Name

HAMAMATSU PHOTONICS ELECTRON TUBE DIVISION

City/State/Country

Iwata City Shizuoka, JP

Establishment Address

314-5, Shimokanzo, Iwata City Shizuoka 438-0193, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HAMAMATSU PHOTONICS ELECTRON TUBE DIVISION (Owner Number: 10061112)

Owner / Operator Contact Address

314-5, Shimokanzo, Iwata City, JP-22 438-0193, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K182001

PMA Number

N/A

All Registered Proprietary Names

Acucy System; Part Number 1039

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2019-08-23

Official Correspondent

Reo Mukoyama

US Agent Details

Teresa Carroll Business: Hamamatsu Corporation Email: tcarroll@hamamatsu.com Phone: (732) 5373601

Related Public Records

Same Entity

HAMAMATSU PHOTONICS ELECTRON TUBE DIVISION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005586126. Last updated year: 2026. Please use registration number 3005586126 when referencing this establishment in official correspondence.