BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Transdermal Test For Assessment Of Glomerular Filtration Rate

    PMA: P230019 · Supplement: S001 · Decision Dec 15, 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 (TGFR)
    PMA Number
    P230019
    Supplement Number
    S001
    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
    December 15, 2025
    Date Received
    March 4, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    for the addition of the MediBeacon Reusable Sensor to the MediBeacon® Transdermal GFR System and the extension of the Lumitrace component shelf life from 1 year to 2 years.

    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