BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Impedimed Limited

    Reg #: 3004782476 · FEI: 3004782476 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Impedimed Limited
    Registration Number
    3004782476
    FEI Number
    3004782476
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Suite 31C, 12-18 Tryon Rd.
    City
    Lindfield New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K232089

    Owner / Operator

    Firm Name
    Impedimed Limited
    Operator Number
    10023581
    Address
    Suite 31C, 12-18 Tryon Rd.
    City
    Lindfield
    State
    New South Wales
    Postal Code
    2070
    Country
    AU

    US Agent

    Business Name
    ImpediMed Inc.
    Contact Name
    Richard Hines
    Address
    5900 Pasteur Ct Ste 125
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US
    Email
    [email protected]
    Phone
    760 5852104

    Products

    Device Name Product Code
    Plethysmograph, Impedance DSB
    Monitor, Extracellular Fluid, Lymphedema, Extremity OBH
    Analyzer, Body Composition MNW
    Adjunct Monitor, Protein Calorie Malnutrition QJB

    Proprietary Names

    SOZO Pro L-Dex U400 SOZO Extracellular Fluid Analysis Bis Extra Cellular Fluid Analysis BODY COMP ANALYZER, IMP SFB7 IMED-Z FLUID STATUS MONITOR Body Composition Analysis

    Establishment Types

    Manufacture Medical Device