BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Macroduct® Sweat Collection System, Model 3700-SYS

    Reg #: 1717966 · FEI: 1717966 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ELITechGroup Inc
    Registration Number
    1717966
    FEI Number
    1717966
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    370 West 1700 South
    City
    LOGAN
    State
    UT
    ZIP
    84321
    Country
    US

    Regulatory Submissions

    510(k) Number
    K853973

    Owner / Operator

    Firm Name
    ELITechGroup Inc.
    Operator Number
    1717966
    Address
    370 West 1700 South
    City
    Logan
    State
    UT
    Postal Code
    84321
    Country
    US

    Products

    Device Name Product Code
    Device, Iontophoresis, Specific Uses KTB

    Proprietary Names

    Macroduct® Sweat Collection System, Model 3700-SYS Macroduct® Supply Kit, Qty 6 Macroduct® Supply Kit, w/o Dye, Qty 6 Macroduct® Red Electrode Strap, Qty 1 Macroduct® Electrode Cable Assembly Macroduct® Black Electrode Strap, Qty 1 Macroduct® Collection Strap Macroduct Strap, Medium (diam up to 6 cm) Macroduct Strap, Large (diam up to 9 cm) Macroduct Pilogel Discs, Vial of 12 Macroduct Strap, X-Large (diam up to 13 cm) Macroduct Strap Set (1 ea: S, M, L, XL) Macroduct Collector - No Dye Macroduct Collector

    Establishment Types

    Manufacture Medical Device