BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    16 BIT INC

    Reg #: 3033583855 · FEI: 3033583855 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    16 BIT INC
    Registration Number
    3033583855
    FEI Number
    3033583855
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    20 Bay Street, 11th Floor
    City
    Toronto Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    DEN230023

    Owner / Operator

    Firm Name
    16 Bit Inc
    Operator Number
    10091425
    Address
    20 Bay Street, 11th Floor
    City
    Toronto
    State
    Ontario
    Postal Code
    M5J 2N8
    Country
    CA
    Correspondent
    Catriona Syme

    US Agent

    Business Name
    FDAbasics
    Contact Name
    Emily Matorin
    Address
    1 Prospect Park W Apt 4d
    City
    Brooklyn
    State
    NY
    ZIP
    11215
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density SAO

    Proprietary Names

    Rho

    Establishment Types

    Manufacture Medical Device