BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ARJ MEDICAL, LLC. / Gulf Coast Scientific, LLC.

    Reg #: 3004577174 · FEI: 3004577174 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ARJ MEDICAL, LLC. / Gulf Coast Scientific, LLC.
    Registration Number
    3004577174
    FEI Number
    3004577174
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    13812 Wright Cir
    City
    Tampa
    State
    FL
    ZIP
    33626
    Country
    US

    Regulatory Submissions

    510(k) Number
    K052708
    PMA Number
    P170022

    Owner / Operator

    Firm Name
    ARJ MEDICAL, LLC
    Operator Number
    9078060
    Address
    13812 Wright Circle, --
    City
    Tampa
    State
    FL
    Postal Code
    33626
    Country
    US

    Products

    Device Name Product Code
    Test, Urea Adult And Pediatric (Breath), OZA
    Helicobacter Pylori LYR

    Proprietary Names

    PyloPlus 13C Urea Breath Test PyloPlus UBT System PyloPlus Urea Breath Test PYLO PLUS

    Establishment Types

    Manufacture Medical Device