BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    intelliMammo densityAI

    Reg #: 3014343888 · FEI: 3014343888 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Densitas Inc.
    Registration Number
    3014343888
    FEI Number
    3014343888
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    #66, 1344 Summer Street, Suite 311B
    City
    Halifax Nova Scotia
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K192973

    Owner / Operator

    Firm Name
    Densitas Inc
    Operator Number
    10057237
    Address
    #66, 1344 Summer Street, Suite 311B
    City
    Halifax
    State
    Nova Scotia
    Postal Code
    B3H 0A8
    Country
    CA

    US Agent

    Business Name
    Regulatory Pharma World
    Contact Name
    Mateo Carrasco
    Address
    1815 Barker Dr
    City
    Winter Park
    State
    FL
    ZIP
    32789
    Country
    US
    Email
    [email protected]
    Phone
    407 2849480

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    intelliMammo densityAI

    Establishment Types

    Manufacture Medical Device