BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    BARCO N.V.

    Reg #: 9613188 · FEI: 3004455125 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    74
    Establishment Types
    3
    Classifications
    9

    Registration Details

    Registration Name
    BARCO N.V.
    Registration Number
    9613188
    FEI Number
    3004455125
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    35 PRESIDENT KENNEDYPARK
    City
    KORTRIJK West-Vlaanderen
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K151505

    Owner / Operator

    Firm Name
    BARCO NV
    Operator Number
    9031117
    Address
    Beneluxpark 21
    City
    Kortrijk
    State
    West-Vlaanderen
    Postal Code
    8500
    Country
    BE

    US Agent

    Business Name
    Barco Inc.
    Contact Name
    Roxana Allen
    Address
    3059 Premiere Parkway,Suite 400
    City
    Duluth
    State
    GA
    ZIP
    30097
    Country
    US
    Email
    [email protected]
    Phone
    678 2008674

    Products

    Device Name Product Code
    Display, Diagnostic Radiology PGY
    Display, Cathode-Ray Tube, Medical DXJ
    Camera, Surgical And Accessories KQM
    System, Image Processing, Radiological LLZ
    Whole Slide Imaging System PSY
    Digital Pathology Display PZZ
    Laparoscope, General & Plastic Surgery GCJ
    Instrument, Quality-Assurance, Radiologic LHO
    System, Digital Image Communications, Radiological LMD

    Proprietary Names

    Coronis uniti Uniti MDMC-12133 Coronis Uniti NMS Nexxis MNA MNA-110 Nexxis Nexxis NMS MNA-240 MNA-120 Nexxis OR MNA-420 MNA-440 MDNC-2123 Nio Color 2MP MDSC-8258 MDSC-2226 MDSC-2232 MDSC-8232 AMM215WTD MDSC-8255 AMM215WTTP MDSC-8358 MDSC-2326 AMM240ED MDSC-2324 MDSC-8231 MDSC-8331 MDSC-8427 MDFC-8232 MDSC-8532 MDSC-8527 Vividimage®32 4K DL Precise NMS Network Management Software MNC-180 MDNC-6121 MDNG-6221 MDNC-12130 Nio Fusion 12MP MDPC-8127 MDNC-3421 Coronis OneLook MDMC-32133 MDEC-2523 MDCC-6530 Coronis Fusion 6MP Coronis Fusion 4MP Intuitive Workflow Tools (IWT) MDCC-4430 MDNC-8132 Nio Color 8MP QAWeb Enterprise MDCG-5221 Coronis 5MP MDNG-5221 Nio 5MP LED MDNC-2221 Nio Color 2MP HB MDRC-1219 MDRC-1219 HB MDRC-2222 MDRC-2324 MDRC-2321 MDRC-2422 MDRC-2424 MDRC-1419 MDRC-8132 MDRC-8127 MDRC-2421 MDNC-3521 MDNC-2521 Nio Color 3MP

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility