BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Envoy 500+

    Reg #: 1000455123 · FEI: 1000455123 · Expires 2025
    View on FDA
    Products
    6
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    BIOTECNICA INSTRUMENTS, Srl
    Registration Number
    1000455123
    FEI Number
    1000455123
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VIA LICENZA 18
    City
    ROME Roma
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K945271

    Owner / Operator

    Firm Name
    CarboLink Corporate Consulting, LLC
    Operator Number
    9038786
    Address
    634 Regency Hills Dr.
    City
    Collegeville
    State
    PA
    Postal Code
    19426
    Country
    US
    Correspondent
    Larry A Carbonari

    US Agent

    Business Name
    CARBOLINK CORPORATE CONSULTING, LLC
    Contact Name
    LARRY A. CARBONARI
    Address
    634 Regency Hills Dr
    City
    Collegeville
    State
    PA
    ZIP
    19426
    Country
    US
    Email
    [email protected]
    Phone
    732 3302096

    Products

    Device Name Product Code
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion-Specific, Chloride CGZ
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Electrode, Ion Specific, Potassium CEM
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE

    Proprietary Names

    Envoy 500+

    Establishment Types

    Manufacture Medical Device