BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Medlink FDR, Medlink FDR-PLUS, Medlink SDR, Medlink SDR-PLUS, Medlink CDR

    Reg #: 2433615 · FEI: 2433615 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MEDLINK IMAGING, LLC.
    Registration Number
    2433615
    FEI Number
    2433615
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1 CHAPIN RD STE 3
    City
    Pine Brook
    State
    NJ
    ZIP
    07058
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193360

    Owner / Operator

    Firm Name
    MEDLINK IMAGING
    Operator Number
    2433615
    Address
    1 CHAPIN ROAD, UNIT 3, --
    City
    Pine Brook
    State
    NJ
    Postal Code
    07058
    Country
    US
    Correspondent
    Max Rodriguez

    Products

    Device Name Product Code
    System, X-Ray, Stationary KPR
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB

    Proprietary Names

    Medlink FDR, Medlink FDR-PLUS, Medlink SDR, Medlink SDR-PLUS, Medlink CDR

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198