BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Limbus Contour

    Reg #: 3017927156 · FEI: 3017927156 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    LIMBUS AI
    Registration Number
    3017927156
    FEI Number
    3017927156
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2431 Glamis Pl
    City
    Regina Saskatchewan
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K230575

    Owner / Operator

    Firm Name
    Limbus AI
    Operator Number
    10080198
    Address
    2431 Glamis Pl
    City
    Regina
    State
    Saskatchewan
    Postal Code
    S4V 1A5
    Country
    CA
    Correspondent
    Jonathan Giambattista

    US Agent

    Business Name
    Medical Device Academy Incorporated
    Contact Name
    Robert Packard
    Address
    345 Lincoln Hill Rd
    City
    Cuttingsville
    State
    VT
    ZIP
    05738
    Country
    US
    Email
    [email protected]
    Phone
    802 2581881

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Limbus Contour

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198