BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    CADScor System

    Reg #: 3008773490 · FEI: 3008773490 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PAUL E. DANCHELL A/S
    Registration Number
    3008773490
    FEI Number
    3008773490
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lyngvej 8
    City
    Jyderup Sjalland
    Country
    DK

    Regulatory Submissions

    510(k) Number
    DEN190047

    Owner / Operator

    Firm Name
    Paul E. Danchell A/S
    Operator Number
    10042718
    Address
    Lyngvej 8
    City
    Jyderup
    State
    DK-NOTA
    Postal Code
    4450
    Country
    DK
    Correspondent
    Claus Jensen

    US Agent

    Business Name
    Natus
    Contact Name
    Courtney Walton
    Address
    3610 County Road 101 S
    City
    Wayzata
    State
    MN
    ZIP
    55391
    Country
    US
    Email
    [email protected]
    Phone
    651 4215870

    Products

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

    Proprietary Names

    CADScor System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)