BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    CADScor System

    Reg #: 3019252624 · FEI: 3019252624 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ACARIX AS
    Registration Number
    3019252624
    FEI Number
    3019252624
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Ryvangs Alle 81-83
    City
    Hellerup Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    DEN190047

    Owner / Operator

    Firm Name
    Acarix AS
    Operator Number
    10081966
    Address
    Ryvangs Alle 81-83
    City
    Hellerup
    State
    Hovedstaden
    Postal Code
    DK-2900
    Country
    DK

    US Agent

    Business Name
    Acarix USA Inc
    Contact Name
    Carma Connely
    Address
    287 Park Ave S Ste 700
    City
    New York City
    State
    NY
    ZIP
    10010
    Country
    US
    Email
    [email protected]
    Phone
    949 6366530

    Products

    Device Name Product Code
    Coronary Artery Disease Risk Indicator From Acoustic Heart Signals QMW

    Proprietary Names

    CADScor System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device