BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    COPAN ITALIA

    Reg #: 3002444944 · FEI: 3002444944 · Expires 2026
    View on FDA
    Products
    23
    Proprietary Names
    99
    Establishment Types
    2
    Classifications
    23

    Registration Details

    Registration Name
    COPAN ITALIA
    Registration Number
    3002444944
    FEI Number
    3002444944
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    VIA F. PEROTTI, 10, 18
    City
    BRESCIA Lombardy
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K061301

    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
    Correspondent
    ELISABETTA ZANELLA

    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
    Transport Systems, Anaerobic JTX
    System, Transport, Aerobic JTW
    Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System PQA
    Culture Media, Anaerobic Transport JSL
    Culture Media, Non-Selective And Non-Differential JSG
    Culture Media, Non-Propagating Transport JSM
    Device, Specimen Collection LIO
    General Purpose Reagent PPM
    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
    Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections QEP
    Microbial Nucleic Acid Storage And Stabilization Device QBD
    Dna Probe, Nucleic Acid Amplification, Chlamydia MKZ
    Dna-Reagents, Neisseria LSL
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Container, Specimen, Sterile FMH
    Applicator, Absorbent Tipped, Sterile KXG
    Detergent JCB
    Culture Media, Selective And Non-Differential JSJ
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Container, Specimen Mailer And Storage, Sterile KDT
    Culture Media, Selective Broth JSD

    Proprietary Names

    Copan Liquid Amies ESwab BD ESwab Copan Liquid Amies Elution Swab HealthLink Elution Swab Xpert Swab Specimen Collection Kit BD BBL CultureSwab Plus BD BBL CultureSwab Copan Venturi Transystem Copan M40 Transystem HealthLink Transporter BHI (Brain Heart Infusion) Broth THIOBroth BD BBL CultureSwab MaxV Cepheid Liquid Stuart Venturi Transystem CultureSwab ALLIGENCE Copan Venturi Transystem Liquid Stuarts Medium Copan Venturi Transystem Cary-Blair Medium Copan Viral Transystem BD FecalSwab Copan FecalSwab BD FCT UriSponge UriSwab Xpert Urine Specimen Collection Kit Copan Easy-Swab Collection and Transport System BD BBL CultureSwab EZ Sample Diluent Tube Copan SLsolution Snot Buster Saline Solution 0.85% UriSponge-Urine Collection, Transport, and Preservation System MSwab Colibri Daily Verification Kit Colibri Colibri Primary Tube with Saline Colibri Primary Tube with Water Colibri Spreader Colibri Primary Tube for Vitek 2 Xpert Vaginal/Endocervical Specimen Collection Kit Xpert CT/NG Xpert Swab Specimen Collectin Kit 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 MDL UroSwab Urine Transport Container NuFoam Swab Rayon Fiber Swab, Sterile Nylon Fiber Swab, Sterile Cotton Fiber Swab, Sterile Polyester Fiber Swab, Sterile FLOQBrush Buccal Swab CLASSIQSwab Foam Swab, Sterile FLOQSwab HealthLink UTM Cepheid Xpert Xpress Nasopharyngeal Collection Kit Copan Universal Transport Medium UTM-RT Quest Diagnostics VCM BD BBL UVT BD Universal Viral Transport WASP Loop Cleansing Solution Xpert Nasal Sample Collection Kit Xpert Nasopharyngeal Sample Collection Kit BD MAX CG/GC/TV GN Broth Rayon Fiber Swab, Non-Sterile Cotton Fiber Swab, Non-Sterile Polyester Fiber Swab, Non-Sterile Foam Swab, Non-Sterile Nylon Fiber Swab, Non-Sterile eNAT Copan Venturi Transystem Stuarts Medium Copan Venturi Transystem Liquid Amies Medium Copan Universal Transport Medium (UTM-RT) System Dry Swab Tube Plain Dry Screw Cap Tube Sterile Dry Tube BC+ UriFree Copan FLOQSwabs with Empty Tube SELENITEBroth LIMBroth TSBBroth with Salt CABroth

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)