BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Transdermal Test For Assessment Of Glomerular Filtration Rate

    PMA: P230019 · Supplement: S003 · Decision Nov 20, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Transdermal Test For Assessment Of Glomerular Filtration Rate
    Trade Name
    MediBeacon® Transdermal GFR Measurement System (GFR)
    PMA Number
    P230019
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    SDK
    Generic Name
    Transdermal test for Assessment of Glomerular Filtration Rate
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 20, 2025
    Date Received
    September 25, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for a manufacturing site located at Tjoapack, LLC, 341 JD Yarnell Industrial Parkway, Clinton, TN 37716 for labeling and secondary packaging of device.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SDK Transdermal Test For Assessment Of Glomerular Filtration Rate