BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PYLO PLUS

    Reg #: 3004577174 · FEI: 3004577174 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ARJ MEDICAL, LLC. / Gulf Coast Scientific, LLC.
    Registration Number
    3004577174
    FEI Number
    3004577174
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    209 State St E
    City
    OLDSMAR
    State
    FL
    ZIP
    34677
    Country
    US

    Regulatory Submissions

    510(k) Number
    K052708

    Owner / Operator

    Firm Name
    ARJ MEDICAL, INC.
    Operator Number
    9078060
    Address
    209 STATE STREET EAST, --
    City
    Oldsmar
    State
    FL
    Postal Code
    34677
    Country
    US

    Products

    Device Name Product Code
    Helicobacter Pylori LYR

    Proprietary Names

    PYLO PLUS

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device