BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    PyloPlus

    Reg #: 3010837197 · FEI: 3010837197 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    FISCHER ANALYSEN INSTRUMENTE GMBH
    Registration Number
    3010837197
    FEI Number
    3010837197
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Brahestr. 25-27
    City
    Leipzig Saxony
    Country
    DE

    Regulatory Submissions

    PMA Number
    P170022

    Owner / Operator

    Firm Name
    Fischer ANalysen Instrumente GmbH
    Operator Number
    10062455
    Address
    Brahestr. 25-27
    City
    Leipzig
    State
    Saxony
    Postal Code
    04347
    Country
    DE
    Correspondent
    Martin Schaich

    US Agent

    Business Name
    Gulf Coast Scientific, Inc. / ARJ Medical, Inc.
    Contact Name
    Philip Ross
    Address
    209 State Street E.
    City
    Oldsmar
    State
    FL
    ZIP
    34677
    Country
    US
    Email
    [email protected]
    Phone
    813 8551557 ext. 7912

    Products

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

    Proprietary Names

    PyloPlus

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198