BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Edwards Lifesciences LTD

    Reg #: 3015179394 · FEI: 3015179394 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Edwards Lifesciences LTD
    Registration Number
    3015179394
    FEI Number
    3015179394
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    10 Earhart Ave, Shannon Industrial Estates
    City
    Shannon Clare
    Country
    IE

    Owner / Operator

    Firm Name
    Edwards Lifesciences LLC
    Operator Number
    9040666
    Address
    One Edwards Way
    City
    Irvine
    State
    CA
    Postal Code
    92614
    Country
    US
    Correspondent
    Denny Kouri

    US Agent

    Business Name
    EDWARDS LIFESCIENCES LLC
    Contact Name
    Denny Kouri
    Address
    1 Edwards Way
    City
    Irvine
    State
    CA
    ZIP
    92614
    Country
    US
    Email
    [email protected]
    Phone
    949 2502500

    Products

    Device Name Product Code
    Cardiovascular Delivery Catheter System Positioning And Stabilization Device QWA

    Proprietary Names

    PASCAL System - Table PASCAL System - Stabilizer Rail System Edwards Reusable Accessories - Reusable Platform Edwards Reusable Accessories - Reusable Cradle Edwards EVOQUE Accessories Edwards Reusable Rail Extension Edwards Reusable Accessories - Reusable Plate Edwards Stabilizer Rail System Edwards Stabilizer Set Edwards Rail Tray SAPIEN M3 TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM Edwards Reusable Rail Edwards EVOQUE Stabilizer

    Establishment Types

    Manufacture Medical Device