BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    GE Voluson S8

    Reg #: 3009617712 · FEI: 3009617712 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    CANUTE INTERNATIONAL MEDICAL SERVICES (CANADA) INC
    Registration Number
    3009617712
    FEI Number
    3009617712
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1193 North Service Road West, Unit C2
    City
    Oakville Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K103649

    Owner / Operator

    Firm Name
    Canute International Medical Services (Canada) Inc
    Operator Number
    10041412
    Address
    1193 North Service Road West, Unit C2
    City
    Oakville
    State
    Ontario
    Postal Code
    L6M 2V8
    Country
    CA

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177 ext. 322

    Products

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

    Proprietary Names

    GE Voluson S8

    Establishment Types

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