BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Edwards Lifesciences Ireland Limited

    Reg #: 3017298588 · FEI: 3017298588 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    31
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    Edwards Lifesciences Ireland Limited
    Registration Number
    3017298588
    FEI Number
    3017298588
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    National Technology Park, Castletroy
    City
    Limerick Munster
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K200258
    PMA Number
    P200015

    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
    Contact Name
    Denny Kouri
    Address
    One 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
    Introducer, Catheter DYB
    Pulmonary Valve Prosthesis Percutaneously Delivered NPV
    Mitral Valve Repair Devices NKM
    Aortic Valve, Prosthesis, Percutaneously Delivered NPT
    Prosthesis, Mitral Valve, Percutaneously Delivered NPU

    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 Edwards eSheath Introducer Set Edwards SAPIEN 3 Transcatheter Heart Valve Edwards Crimper Edwards Commander Delivery System Edwards SAPIEN 3 Transcather Pulmonary Valve System with Alterra Adaptive Prestent Edwards SAPIEN 3 Pulmonic Delivery System Edwards SAPIEN 3 Transcatheter Pulmonic Valve Delivery System PASCAL Precision Transcatheter Valve Repair System Edwards Certitude Introducer Sheath Edwards Certitude Delivery System Edwards SAPIEN 3 Ultra Transcatheter Heart Valve Edwards Certitude Introducer Sheath Set Edwards eSheath Introducer Set- 914ES eSheath- 914ES Edwards eSheath Introducer Set- 916ES eSheath- 916ES Edwards COMMANDER Delivery System Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve

    Establishment Types

    Manufacture Medical Device