BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    conductance catheter

    Reg #: 3003493679 · FEI: 3003493679 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    CD LEYCOM
    Registration Number
    3003493679
    FEI Number
    3003493679
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Asveldweg 2
    City
    Hengelo Overijssel
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K031599

    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
    Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) DRO
    Transducer, Pressure, Catheter Tip DXO
    Catheter, Intravascular, Diagnostic DQO

    Proprietary Names

    conductance catheter 4F pressure-volume catheter CD Leycom 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