BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    CD LEYCOM

    Reg #: 3003493679 · FEI: 3003493679 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    CD LEYCOM
    Registration Number
    3003493679
    FEI Number
    3003493679
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Asveldweg 2
    City
    Hengelo Overijssel
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K003020

    Owner / Operator

    Firm Name
    CD Leycom
    Operator Number
    9043127
    Address
    ASVELDWEG 2, --
    City
    Hengelo
    State
    NL-NOTA
    Postal Code
    7556BP
    Country
    NL
    Correspondent
    Dinant Goorhorst

    US Agent

    Business Name
    Qserve Group US Inc
    Contact Name
    Mindy McCann
    Address
    350 S Main Street, Suite 309
    City
    Doylestown
    State
    PA
    ZIP
    18901
    Country
    US
    Email
    [email protected]
    Phone
    424 2718169

    Products

    Device Name Product Code
    Amplifier And Signal Conditioner, Transducer Signal DRQ
    Catheter, Intravascular, Diagnostic DQO
    Transducer, Pressure, Catheter Tip DXO
    Catheter, Ultrasound, Intravascular OBJ
    Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) DRO

    Proprietary Names

    Cardiac Function Laboratory CD Leycom IntraCardiac Analyzer CFL-M Inca conductance catheter 7F pressure-volume catheter 4F pressure-volume catheter intracardiac ECG

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device