BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    MReye® Flipper® Detachable Embolization Coil

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

    510(k) Number
    K150964

    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
    Device, Vascular, For Promoting Embolization KRD

    Proprietary Names

    MReye® Flipper® Detachable Embolization Coil Flipper® Delivery System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device