BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    BoneMRI

    Reg #: 3027986210 · FEI: 3027986210 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MRIGUIDANCE B.V.
    Registration Number
    3027986210
    FEI Number
    3027986210
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Maliesingel 23
    City
    Utrecht
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K233030

    Owner / Operator

    Firm Name
    MRIguidance B.V.
    Operator Number
    10088516
    Address
    Maliesingel 23
    City
    Utrecht
    State
    NL-UT
    Postal Code
    3581BG
    Country
    NL
    Correspondent
    Marijn van Stralen

    US Agent

    Business Name
    TABS INC
    Contact Name
    Jacob Willemsen
    Address
    228E 45th Street, Suite 9E, Suite 9E
    City
    Grand Central
    State
    NY
    ZIP
    10017
    Country
    US
    Email
    [email protected]
    Phone
    347 6945321

    Products

    Device Name Product Code
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    BoneMRI

    Establishment Types

    Manufacture Medical Device