BEUDAMED
    FDA Registration Active 🇨🇱 Chile

    DIGIT SYSTEMS SPA

    Reg #: 3030210400 · FEI: 3030210400 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    DIGIT SYSTEMS SPA
    Registration Number
    3030210400
    FEI Number
    3030210400
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Victoria 427, San Bernardo
    City
    Santiago Region Metropolitana
    Country
    CL

    Regulatory Submissions

    510(k) Number
    K133657

    Owner / Operator

    Firm Name
    Digit Systems SpA
    Operator Number
    10094992
    Address
    Victoria 427, San Bernardo
    City
    Santiago
    State
    Region Metropolitana
    Postal Code
    8071064
    Country
    CL
    Correspondent
    Felipe Perez

    US Agent

    Business Name
    Block Imaging Parts and Service
    Contact Name
    Grace Lyon
    Address
    1845 Cedar St
    City
    Holt
    State
    MI
    ZIP
    48842
    Country
    US
    Email
    [email protected]
    Phone
    517 6688800

    Products

    Device Name Product Code
    System, Tomography, Computed, Emission KPS

    Proprietary Names

    GE Discovery 710 PET/CT

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device