BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    3Dicom MD

    Reg #: 3024078470 · FEI: 3024078470 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SINGULAR HEALTH PTY LTD
    Registration Number
    3024078470
    FEI Number
    3024078470
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2/41 Discovery Drive
    City
    Bibra Lake Western Australia
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K222470

    Owner / Operator

    Firm Name
    Singular Health Pty Ltd
    Operator Number
    10086614
    Address
    2/41 Discovery Drive
    City
    Bibra Lake
    State
    Western Australia
    Postal Code
    6163
    Country
    AU
    Correspondent
    Andre Marchezini Rocha

    US Agent

    Business Name
    Primority Ltd
    Contact Name
    Fabrizzio Vasquez
    Address
    9160 Forum Corporate Pkwy Ste 350
    City
    Fort Myers
    State
    FL
    ZIP
    33905
    Country
    US
    Email
    [email protected]
    Phone
    415 8710682

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    3Dicom MD

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device