BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    Edwards SAPIEN 3 Transcatheter Heart Valve

    Reg #: 3007063218 · FEI: 3007063218 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    EDWARDS LIFESCIENCES (SINGAPORE) Pte Ltd
    Registration Number
    3007063218
    FEI Number
    3007063218
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    35 Changi North Crescent
    City
    Changi South East
    Country
    SG

    Regulatory Submissions

    PMA Number
    P140031

    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
    Aortic Valve, Prosthesis, Percutaneously Delivered NPT
    Prosthesis, Mitral Valve, Percutaneously Delivered NPU

    Proprietary Names

    Edwards SAPIEN 3 Transcatheter Heart Valve Edwards Crimper Edwards Commander Delivery System Edwards Certitude Delivery System Edwards Certitude Introducer Sheath Edwards Certitude Introducer Sheath Set Edwards SAPIEN 3 Ultra Transcatheter Heart Valve eSheath- 916ES eSheath- 914ES Edwards eSheath Introducer Set- 914ES Edwards eSheath Introducer Set- 916ES Edwards COMMANDER Delivery System Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve

    Establishment Types

    Manufacture Medical Device