BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    NRT X-RAY A/S

    Reg #: 1000188474 · FEI: 1000188474 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    NRT X-RAY A/S
    Registration Number
    1000188474
    FEI Number
    1000188474
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    BIRKEGAARDSVEJ 16
    City
    HASSELAGER Midtjylland
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K033486

    Owner / Operator

    Firm Name
    NRT X-RAY A/S
    Operator Number
    9059076
    Address
    BIRKEGAARDSVEJ 16, --
    City
    HASSELAGER
    State
    DK-NOTA
    Postal Code
    8361
    Country
    DK

    US Agent

    Business Name
    REGULATORY INSIGHT, INC.
    Contact Name
    Kevin Walls
    Address
    33 Golden Eagle Lane
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Interventional Fluoroscopic X-Ray System OWB

    Proprietary Names

    GE PRECISION MPI Intelli C Adora DRFi

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device