BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Acucy System; Part Number 1039

    Reg #: 3005586126 · FEI: 3005586126 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HAMAMATSU PHOTONICS ELECTRON TUBE DIVISION
    Registration Number
    3005586126
    FEI Number
    3005586126
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    314-5, Shimokanzo
    City
    Iwata City Shizuoka
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K182001

    Owner / Operator

    Firm Name
    HAMAMATSU PHOTONICS ELECTRON TUBE DIVISION
    Operator Number
    10061112
    Address
    314-5, Shimokanzo
    City
    Iwata City
    State
    Shizuoka
    Postal Code
    438-0193
    Country
    JP
    Correspondent
    Reo Mukoyama

    US Agent

    Business Name
    Hamamatsu Corporation
    Contact Name
    Teresa Carroll
    Address
    360 Foothill Road
    City
    Bridgewater
    State
    NJ
    ZIP
    08807
    Country
    US
    Email
    [email protected]
    Phone
    732 5373601

    Products

    Device Name Product Code
    Devices Detecting Influenza A, B, And C Virus Antigens PSZ

    Proprietary Names

    Acucy System; Part Number 1039

    Establishment Types

    Manufacture Medical Device