BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    QAngio XA 3D

    Reg #: 9614587 · FEI: 3006974930 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MEDIS MEDICAL IMAGING SYSTEMS, B.V.
    Registration Number
    9614587
    FEI Number
    3006974930
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SCHUTTERSVELD 9
    City
    LEIDEN Zuid-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K182611

    Owner / Operator

    Firm Name
    MEDIS HOLDING B.V.
    Operator Number
    9039556
    Address
    SCHUTTERSVELD 9
    City
    LEIDEN
    State
    Zuid-Holland
    Postal Code
    2316 XG
    Country
    NL

    US Agent

    Business Name
    Medis Medical Imaging Systems Inc.
    Contact Name
    Vitalie Cojan
    Address
    9360 Falls Of Neuse Rd Ste 103
    City
    Raleigh
    State
    NC
    ZIP
    27615
    Country
    US
    Email
    [email protected]
    Phone
    919 2787888 ext. 103

    Products

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

    Proprietary Names

    QAngio XA 3D

    Establishment Types

    Manufacture Medical Device