BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    RESONANCE HEALTH ANALYSIS SERVICES PTY LTD

    Reg #: 3005450718 · FEI: 3005450718 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
    Registration Number
    3005450718
    FEI Number
    3005450718
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    141 Burswood Road
    City
    Burswood Western Australia
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K213776

    Owner / Operator

    Firm Name
    RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
    Operator Number
    9079481
    Address
    141 Burswood Road, --
    City
    Burswood
    State
    Western Australia
    Postal Code
    6100
    Country
    AU

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    System, Nuclear Magnetic Resonance Imaging LNH
    Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox PCS
    Phantom, Anthropomorphic, Radiographic IXG
    System, Image Processing, Radiological LLZ

    Proprietary Names

    LiverSmart HepaFatSmart HepaFat-Scan R2-MRI Analysis System (FerriScan) FerriScan Phantom T1CMR Phantom (1.5T) T1CMR Phantom (3T) T2CMR Phantom R2*/T2* Phantom FerriSmart FerriScan Cardiac T2*

    Establishment Types

    Manufacture Medical Device