BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Fusion Bx

    Reg #: 3011853771 · FEI: 3011853771 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Focal Healthcare Inc.
    Registration Number
    3011853771
    FEI Number
    3011853771
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10 Morrow Ave., Unit 101
    City
    Toronto Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K153166

    Owner / Operator

    Firm Name
    Focal Healthcare Inc.
    Operator Number
    10051236
    Address
    10 Morrow Ave., Unit 101
    City
    Toronto
    State
    Ontario
    Postal Code
    M6R2J1
    Country
    CA
    Correspondent
    Chicuong La

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Fusion Bx

    Establishment Types

    Manufacture Medical Device