BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Gore European Warehouse Support

    Reg #: 3015138222 · FEI: 3015138222 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    3

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    Registration Details

    Registration Name
    Gore European Warehouse Support
    Registration Number
    3015138222
    FEI Number
    3015138222
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Doctor Paul Janssenweg 150
    City
    Tilburg Noord-Brabant
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K152913

    Owner / Operator

    Firm Name
    W. L. GORE & ASSOCIATES, INC.
    Operator Number
    9925013
    Address
    1505 North Fourth Street
    City
    Flagstaff
    State
    AZ
    Postal Code
    86004
    Country
    US
    Correspondent
    Lisa Wells

    US Agent

    Business Name
    W. L. GORE & ASSOCIATES, INC.
    Contact Name
    Lisa Wells
    Address
    1505 N Fourth St.
    City
    Flagstaff
    State
    AZ
    ZIP
    86004
    Country
    US
    Email
    [email protected]
    Phone
    928 8644219

    Products

    Device Name Product Code
    Introducer, Catheter DYB
    Suture, Surgical, Absorbable, Polydioxanone NEW
    Catheter, Intravascular Occluding, Temporary MJN

    Proprietary Names

    GORE TIPS Set SutureTOOL system GORE DRYSEAL FLEX INTRODUCER SHEATH GORE® Molding and Occlusion Balloon Catheter

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device