BEUDAMED
    FDA Registration Active 🇨🇳 China

    Diagnostic Ultrasound System, Models: Acclarix AX18,

    Reg #: 3003971136 · FEI: 3003971136 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    EDAN INSTRUMENTS, INC.
    Registration Number
    3003971136
    FEI Number
    3003971136
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K202856

    Owner / Operator

    Firm Name
    EDAN INSTRUMENTS, INC.
    Operator Number
    9055347
    Address
    #15 Jinhui Road,Jinsha Community, Kengzi Sub-District, Pingshan District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518122
    Country
    CN

    US Agent

    Business Name
    Edan Diagnostics, Inc
    Contact Name
    Chao Lin
    Address
    9918 Via Pasar, San Diego CA
    City
    San Diego
    State
    CA
    ZIP
    92126
    Country
    US
    Email
    [email protected]
    Phone
    858 7503066

    Products

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

    Proprietary Names

    Diagnostic Ultrasound System, Models: Acclarix AX18, Diagnostic Ultrasound System, Models: Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Diagnostic Ultrasound System, Models: Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25, Acclarix LX28 Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28,

    Establishment Types

    Manufacture Medical Device