BEUDAMED
    FDA Registration Active 🇩🇴 Dominican Republic

    EV1000 Clinical Platform

    Reg #: 9615817 · FEI: 3003081151 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG
    Registration Number
    9615817
    FEI Number
    3003081151
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PARQUE INDUSTRIAL ITABO, KM. 18.5 CARR. SANCHEZ
    City
    HAINA San Cristobal
    Country
    DO

    Regulatory Submissions

    510(k) Number
    K160552

    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
    Plethysmograph, Impedance DSB
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    EV1000 Clinical Platform EV1000 Clinical Platform Non-Invasive (NI) and ClearSight Finger Cuffs or ClearSight System Pressure Controller Kit Pressure Controller

    Establishment Types

    Manufacture Medical Device