BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    Relu Engine

    Reg #: 3031915908 · FEI: 3031915908 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    RELU BV
    Registration Number
    3031915908
    FEI Number
    3031915908
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Kapeldreef 60
    City
    Leuven Brabant Wallon
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K233925

    Owner / Operator

    Firm Name
    Relu BV
    Operator Number
    10091216
    Address
    Kolonel Begaultlaan 1A/51
    City
    Leuven
    State
    Brabant Wallon
    Postal Code
    3012
    Country
    BE

    US Agent

    Business Name
    Prime Path MedTech
    Contact Name
    William Jacqmein
    Address
    811 Lakeview Dr
    City
    Shoreview
    State
    MN
    ZIP
    55126
    Country
    US
    Email
    [email protected]
    Phone
    404 2166190

    Products

    Device Name Product Code
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    Relu Engine Relu Creator

    Establishment Types

    Manufacture Medical Device