BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    QFR

    Reg #: 3038136528 · FEI: 3038136528 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    QFR SOLUTIONS BV
    Registration Number
    3038136528
    FEI Number
    3038136528
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Schuttersveld 9
    City
    Leiden Zuid-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K243769

    Owner / Operator

    Firm Name
    QFR Solutions bv
    Operator Number
    10090409
    Address
    Schuttersveld 9
    City
    Leiden
    State
    Zuid-Holland
    Postal Code
    2316 XG
    Country
    NL
    Correspondent
    Bob Goedhart

    US Agent

    Business Name
    Medis Medical Imaging Systems Inc.
    Contact Name
    Keith Irby
    Address
    9360 Falls of Neuse, Suite 103
    City
    Raleigh
    State
    NC
    ZIP
    27615
    Country
    US
    Email
    [email protected]
    Phone
    919 2787888

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device QHA

    Proprietary Names

    QFR

    Establishment Types

    Manufacture Medical Device