BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Nanoduct® Neonatal Sweat Analysis System, Model 1030

    Reg #: 1717966 · FEI: 1717966 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    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
    K010031

    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

    Nanoduct® Neonatal Sweat Analysis System, Model 1030 Nanoduct® Neg (-) Black Holder Nanoduct® Calibration Standard Plate Nanoduct® Electrode Strap Nanoduct® Attachment Strap Retainer Post Nanoduct® Electrode Cable Set Assembly Nanoduct® Supply Kit, Qty 6 Nanoduct® Pos (+) Red Holder Nanoduct® Conductivity Sensor Cell, Qty 1 Nanoduct® Electrode Strap, medium qty 1 Nanoduct® Electrode Strap, large qty 1

    Establishment Types

    Manufacture Medical Device