BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Copan M40 Transystem

    Reg #: 3002444944 · FEI: 3002444944 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    COPAN ITALIA
    Registration Number
    3002444944
    FEI Number
    3002444944
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VIA F. PEROTTI, 10, 18
    City
    BRESCIA Lombardy
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K946284

    Owner / Operator

    Firm Name
    COPAN ITALIA Spa
    Operator Number
    9016900
    Address
    Via F. Perotti 10, 18
    City
    Brescia
    State
    IT-BS
    Postal Code
    25125
    Country
    IT

    US Agent

    Business Name
    Copan Diagnostics, Inc.
    Contact Name
    FABRIZIO MAZZOCCHI
    Address
    26055 Jefferson Avenue
    City
    Murrieta
    State
    CA
    ZIP
    92562
    Country
    US
    Email
    [email protected]
    Phone
    951 8376897

    Products

    Device Name Product Code
    Culture Media, Non-Propagating Transport JSM

    Proprietary Names

    Copan M40 Transystem BD BBL CultureSwab HealthLink Transporter Copan Venturi Transystem BD BBL CultureSwab Plus

    Establishment Types

    Manufacture Medical Device