BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FOCALYX TECHNOLOGIES

    Reg #: 3016567400 · FEI: 3016567400 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    FOCALYX TECHNOLOGIES
    Registration Number
    3016567400
    FEI Number
    3016567400
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2140 W 68th St Ste 406
    City
    Hialeah
    State
    FL
    ZIP
    33016
    Country
    US

    Regulatory Submissions

    510(k) Number
    K170250

    Owner / Operator

    Firm Name
    Focalyx Technologies
    Operator Number
    10062693
    Address
    2140 West 68th Street, Suite 204
    City
    Hialeah
    State
    FL
    Postal Code
    33016
    Country
    US
    Correspondent
    Fernando J Bianco

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Focalyx Fusion Smartblate

    Establishment Types

    Manufacture Medical Device