BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BION Direct Identification

    Reg #: 1419968 · FEI: 1419968 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BION ENTERPRISES, LTD.
    Registration Number
    1419968
    FEI Number
    1419968
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    455 State St Ste 100
    City
    DES PLAINES
    State
    IL
    ZIP
    60016
    Country
    US

    Regulatory Submissions

    510(k) Number
    K890616

    Owner / Operator

    Firm Name
    BION ENTERPRISES, LTD.
    Operator Number
    1419968
    Address
    455 STATE STREET,, SUITE 100
    City
    Des Plaines
    State
    IL
    Postal Code
    60016
    Country
    US
    Correspondent
    NADINE M SHABAT

    Products

    Device Name Product Code
    Quality Control Slides LJG

    Proprietary Names

    BION Direct Identification Control Slides

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device