BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Zenith Alpha 2, Thoracic Endovascular Graft, Distal Extension

    Reg #: 3002808486 · FEI: 3002808486 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    WILLIAM COOK EUROPE APS
    Registration Number
    3002808486
    FEI Number
    3002808486
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SANDET 6
    City
    BJAEVERSKOV Sjalland
    Country
    DK

    Regulatory Submissions

    PMA Number
    P140016

    Owner / Operator

    Firm Name
    WILLIAM COOK EUROPE APS
    Operator Number
    9053266
    Address
    SANDET 6, DK-4632, --
    City
    BJAEVERSKOV
    State
    DK-NOTA
    Postal Code
    --
    Country
    DK

    US Agent

    Business Name
    Cook Medical Holdings
    Contact Name
    Matt Graf
    Address
    750 Daniels Way
    City
    BLOOMINGTON
    State
    IN
    ZIP
    47404
    Country
    US
    Email
    [email protected]
    Phone
    812 3392235

    Products

    Device Name Product Code
    System, Endovascular Graft, Aortic Aneurysm Treatment MIH

    Proprietary Names

    Zenith Alpha 2, Thoracic Endovascular Graft, Distal Extension Zenith Alpha, Thoracic Endovascular Graft, Proximal Tapered Component Zenith Alpha, Thoracic Endovascular Graft, Distal Extension Zenith Alpha, Thoracic Endovascular Graft, Proximal Component Zenith Alpha, Thoracic Endovascular Graft, Distal Component Zenith Alpha 2, Thoracic Endovascular Graft, Distal Component Zenith Alpha 2, Thoracic Endovascular Graft, Proximal Tapered Component Zenith Alpha 2, Thoracic Endovascular Graft, Proximal Component

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device