BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Ranger™ Paclitaxel-Coated PTA Balloon Catheter

    Reg #: 3005969022 · FEI: 3005969022 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HEMOTEQ
    Registration Number
    3005969022
    FEI Number
    3005969022
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Adenauerstasse 15
    City
    Wurselen North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    PMA Number
    P190019

    Owner / Operator

    Firm Name
    Hemoteq
    Operator Number
    10078693
    Address
    Adenauerstasse 15
    City
    Wurselen
    State
    North Rhine-Westphalia
    Postal Code
    52146
    Country
    DE
    Correspondent
    Ralph Engbrodt

    US Agent

    Business Name
    Freudenberg Medical, LLC
    Contact Name
    Juan Carlos Llamas
    Address
    1110 Mark Ave.
    City
    Carpinteria
    State
    CA
    ZIP
    93013
    Country
    US
    Email
    [email protected]
    Phone
    805 5765317

    Products

    Device Name Product Code
    Drug-Eluting Peripheral Transluminal Angioplasty Catheter ONU

    Proprietary Names

    Ranger™ Paclitaxel-Coated PTA Balloon Catheter

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)