BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Disposable Concentric Needle Electrode

    Reg #: 3008617703 · FEI: 3008617703 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIONEN SRL
    Registration Number
    3008617703
    FEI Number
    3008617703
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via P. Petrocchi, 42/1
    City
    Florence Firenze
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K092973

    Owner / Operator

    Firm Name
    Bionen SRL
    Operator Number
    10034049
    Address
    Via P. Petrocchi, 42/1
    City
    Florence
    State
    Firenze
    Postal Code
    50127
    Country
    IT
    Correspondent
    Monia Nencioni

    US Agent

    Business Name
    Amenichi
    Contact Name
    Allison Scott
    Address
    222 Merchandise Mart Plz, Ste 1230
    City
    Chicago
    State
    IL
    ZIP
    60654
    Country
    US
    Email
    [email protected]
    Phone
    317 3720276

    Products

    Device Name Product Code
    Electrode, Needle, Diagnostic Electromyograph IKT
    Electrode, Needle GXZ

    Proprietary Names

    Disposable Concentric Needle Electrode Disposable Monopolar/Subdermal Needle Electrode Disposable Monopolar Needle Electrode

    Establishment Types

    Manufacture Medical Device