BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Copan WASP

    Reg #: 3009288740 · FEI: 3009288740 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    35
    Establishment Types
    2
    Classifications
    14

    Registration Details

    Registration Name
    Copan WASP
    Registration Number
    3009288740
    FEI Number
    3009288740
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Via Achille Grandi, 32
    City
    Brescia Lombardy
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K251511

    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 Plate Imaging System For Qualitative Assessment Of Resistant Organisms QQY
    Microbial Colony Image Assessment System PPU
    Slides, Microscope KEW
    Bath, Incubators/Water, All JTQ
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Station, Pipetting And Diluting, For Clinical Use JQW
    Fiber, Medical, Absorbent FRL
    Device, Microtiter Diluting/Dispensing JTC
    Calculator/Data Processing Module, For Clinical Use JQP
    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
    Detergent JCB
    Automated Colony Counter KZB

    Proprietary Names

    PhenoMATRIX WASP Microscope Slides WASPLab Hardy SpeedStreakers InfoLab Loops Dove Medical Supply Loops HealthLink Inc. Loops and Needles Inoculation Loops Inoculation Needles BD Inoculation Loops Inoculation Spreaders Troy Biologicals Loops and Needles Disposable Transfer Pipettes Transfer Pipettes Double Spreader Sputum Dipper UniVerse® dispensing tube UniVerse® Dispensing Tube - Bottle MSwab bag for UniVerse UniVerse Liquid Dispensation in Tube WASP Drip Pads Disposable Drip Tray UniVerse Disposable Drip Tray WASP Collaborative Station WASP-FLO Colibri Daily Verification Kit Colibri Colibri Primary Tube with Saline Colibri Primary Tube with Water Colibri Spreader Colibri Primary Tube for Vitek 2 WASP Loop Cleansing Solution WASPLAB PHENOMATRIX App

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility