BEUDAMED
    FDA Registration Active 🇩🇴 Dominican Republic

    HemoSphere

    Reg #: 9615817 · FEI: 3003081151 · Expires 2025
    View on FDA
    Products
    8
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    8

    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
    K231248

    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
    Transducer, Blood-Pressure, Extravascular DRS
    Catheter, Intravascular, Diagnostic DQO
    Computer, Diagnostic, Programmable DQK
    Catheter, Oximeter, Fiber-Optic DQE
    Catheter, Flow Directed DYG
    Plethysmograph, Impedance DSB
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Adjunctive Predictive Cardiovascular Indicator QAQ

    Proprietary Names

    HemoSphere FloTrac Jr sensor Swan-Ganz Jr catheter ClearSight Jr finger cuff

    Establishment Types

    Manufacture Medical Device