BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Edwards Lifesciences Holding B.V.

    Reg #: 3042941992 · FEI: 3042941992 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Edwards Lifesciences Holding B.V.
    Registration Number
    3042941992
    FEI Number
    3042941992
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    CENTERPOINT 1, 4TH FLOOR, HOOGOORDDREEF 60
    City
    AMSTERDAM Noord-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K140312

    Owner / Operator

    Firm Name
    Becton, Dickinson and Company
    Operator Number
    10093301
    Address
    17200 Laguna Canyon Road
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US

    US Agent

    Business Name
    BECTON, DICKINSON AND COMPANY
    Contact Name
    Karen O'Leary
    Address
    17200 Laguna Canyon Rd
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 6109179

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Plethysmograph, Impedance DSB
    Oximeter DQA

    Proprietary Names

    EV1000 Clinical Platform NI EV1000NI Clearsight EV1000 Non-invasive Clearsight system Clearsight finger cuff Nexfin Model 2 Nexfin; Nexfin_HD

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility