BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    EDWARDS LIFESCIENCES (SINGAPORE) Pte Ltd

    Reg #: 3007063218 · FEI: 3007063218 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    39
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    EDWARDS LIFESCIENCES (SINGAPORE) Pte Ltd
    Registration Number
    3007063218
    FEI Number
    3007063218
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    35 Changi North Crescent
    City
    Changi South East
    Country
    SG

    Regulatory Submissions

    PMA Number
    P220003

    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 Kouri
    Address
    ONE EDWARDS WAY
    City
    Irvine
    State
    CA
    ZIP
    92614
    Country
    US
    Email
    [email protected]
    Phone
    949 2506827

    Products

    Device Name Product Code
    Mitral Valve Repair Devices NKM
    Heart-Valve, Non-Allograft Tissue LWR
    Pulmonary Valve Prosthesis Percutaneously Delivered NPV
    Percutaneously Delivered Prostheses And Tricuspid Valves NPW
    Aortic Valve, Prosthesis, Percutaneously Delivered NPT
    Replacement Heart-Valve DYE
    Prosthesis, Mitral Valve, Percutaneously Delivered NPU

    Proprietary Names

    PASCAL Precision Transcatheter Valve Repair System INSPIRIS RESILIA Aortic Valve Edwards Pericardial Aortic Bioprosthesis KONECT RESILIA Aortic Valved Conduit MITRIS RESILIA Mitral Valve TRIFORMIS RESILIA Tricuspid Valve EDWARDS INTUITY Elite Valve System 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 Edwards EVOQUE Loading System and Trimmer Edwards EVOQUE EVOQUE tricuspid delivery system, dilator kit, and loading system Edwards EVOQUE valve EVOQUE Qualcrimp crimping accessory Edwards Expandable Introducer Sheath Set Edwards SAPIEN XT Transcatheter Heart Valve Ascendra+ System NovaFlex + Delivery System Crimp Stopper NovaFlex+ System Ascendra+ Delivery System Ascendra + Introducer Sheath Set Edwards Dilator Kit Carpentier-Edwards Perimount Bioprosthesis 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