BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    PDE-GEN3

    Reg #: 9614683 · FEI: 3003794634 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    HAMAMATSU PHOTONICS K.K., SYSTEMS DIVISION
    Registration Number
    9614683
    FEI Number
    3003794634
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    812 JOKO-CHO, CHUO-KU
    City
    HAMAMATSU CITY Shizuoka
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K133719

    Owner / Operator

    Firm Name
    HAMAMATSU PHOTONICS, K.K.
    Operator Number
    8031665
    Address
    325-6 SUNAYAMA-CHO, CHUO-KU, --
    City
    HAMAMATSU CITY
    State
    Shizuoka
    Postal Code
    430-8587
    Country
    JP

    US Agent

    Business Name
    HAMAMATSU CORP.
    Contact Name
    Teresa Carroll
    Address
    360 FOOTHILL RD.
    City
    BRIDGEWATER
    State
    NJ
    ZIP
    08807
    Country
    US
    Email
    [email protected]
    Phone
    732 5373601

    Products

    Device Name Product Code
    System, X-Ray, Angiographic IZI
    Confocal Optical Imaging OWN

    Proprietary Names

    PDE-GEN3

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device