BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Affiniti 70

    Reg #: 3010703925 · FEI: 3010703925 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    MAKAR CONSULTING PTY LTD
    Registration Number
    3010703925
    FEI Number
    3010703925
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 Garigal Road
    City
    Belrose New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K181485

    Owner / Operator

    Firm Name
    Makar Consulting Pty Ltd
    Operator Number
    10062928
    Address
    1 Garigal Road
    City
    Belrose
    State
    New South Wales
    Postal Code
    2085
    Country
    AU
    Correspondent
    Richard J Blunden

    US Agent

    Business Name
    Vomark Technologies, Inc
    Contact Name
    Peter Pekalski
    Address
    406 Diens Drive
    City
    Wheeling
    State
    IL
    ZIP
    60090
    Country
    US
    Email
    [email protected]
    Phone
    312 2539892

    Products

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

    Proprietary Names

    Affiniti 70

    Establishment Types

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