BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Colibri Primary Tube with Saline

    Reg #: 3002444944 · FEI: 3002444944 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    3

    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
    K232756

    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
    Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry QQV
    Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates QBN
    System, Test, Automated, Antimicrobial Susceptibility, Short Incubation LON

    Proprietary Names

    Colibri Primary Tube with Saline Colibri Daily Verification Kit Colibri Spreader Colibri Primary Tube with Water Colibri Primary Tube for Vitek 2 Colibri

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)