BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    UNEX FMD Device

    Reg #: 3009572889 · FEI: 3009572889 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    UNEX Corporation
    Registration Number
    3009572889
    FEI Number
    3009572889
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2-6-1 Sakae, Naka-ku
    City
    Nagoya Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K131973

    Owner / Operator

    Firm Name
    UNEX Corporation
    Operator Number
    10052174
    Address
    2-6-1 sakae, Naka-ku
    City
    Nagoya
    State
    JP-NOTA
    Postal Code
    460-0008
    Country
    JP
    Correspondent
    Douglas W Blakely

    US Agent

    Business Name
    Technologies For Medicine
    Contact Name
    Douglas Blakely
    Address
    504 Rittiman Rd
    City
    San Antonio
    State
    TX
    ZIP
    78209
    Country
    US
    Email
    [email protected]
    Phone
    210 2404521

    Products

    Device Name Product Code
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    UNEX FMD Device

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device