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Data / Medical devices / Italy / Copan Italia

Copan Italia: FDA-registered device maker in BRESCIA Lombardy, Italy, 19 510(k) clearances

Copan Italia is registered with the FDA (registration 3002444944) in BRESCIA Lombardy, Italy. It lists 23 device types. The FDA files 19 510(k) clearances under its listings, the newest dated October 11, 2024. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Copan Italia
FDA registration number
3002444944
Address
Via F. Perotti, 10, 18, BRESCIA Lombardy, Italy, 25125
Owner or operator
COPAN ITALIA Spa (9016900)
Roles
Contract manufacturer, Manufacturer
First device listed
March 27, 1995
Registered through
2026
Brand names listed
BC+, BD BBL CultureSwab, BD BBL CultureSwab EZ, BD BBL CultureSwab MaxV, BD BBL CultureSwab Plus, BD BBL UVT, BD ESwab, BD FCT and more

Devices it lists

DeviceProduct codeClassRoleSource
Applicator, Absorbent Tipped, Non-SterileKXF1Manufactureraccessdata.fda.gov
Applicator, Absorbent Tipped, SterileKXG1Manufactureraccessdata.fda.gov
Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass SpectrometryQQV2Contract manufactureraccessdata.fda.gov
Container, Specimen Mailer And Storage, SterileKDT1Manufactureraccessdata.fda.gov
Container, Specimen, SterileFMH1Contract manufactureraccessdata.fda.gov
Culture Media, Anaerobic TransportJSL1Manufactureraccessdata.fda.gov
Culture Media, Non-Propagating TransportJSM1Contract manufacturer, Manufactureraccessdata.fda.gov
Culture Media, Non-Selective And Non-DifferentialJSG1Manufactureraccessdata.fda.gov
Culture Media, Selective And Non-DifferentialJSJ1Manufactureraccessdata.fda.gov
Culture Media, Selective BrothJSD1Manufactureraccessdata.fda.gov
DetergentJCB1Contract manufactureraccessdata.fda.gov
Device, Specimen CollectionLIO1Contract manufacturer, Manufactureraccessdata.fda.gov
Dna Probe, Nucleic Acid Amplification, ChlamydiaMKZ1Contract manufactureraccessdata.fda.gov
Dna-Reagents, NeisseriaLSL2Contract manufacturer, Manufactureraccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Manufactureraccessdata.fda.gov
General Purpose ReagentPPM1Manufactureraccessdata.fda.gov
Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured IsolatesQBN2Contract manufactureraccessdata.fda.gov
Microbial Nucleic Acid Storage And Stabilization DeviceQBD2Contract manufacturer, Manufactureraccessdata.fda.gov
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted InfectionsQEP2Contract manufactureraccessdata.fda.gov
System, Test, Automated, Antimicrobial Susceptibility, Short IncubationLON2Contract manufactureraccessdata.fda.gov
System, Transport, AerobicJTW1Manufactureraccessdata.fda.gov
Transport Systems, AnaerobicJTX1Manufactureraccessdata.fda.gov
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection SystemPQA2Contract manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 11, 2024K232565UriSponge™JSMSubstantially EquivalentCopan Italia Spaaccessdata.fda.gov
April 25, 2024K232357Copan Universal Transport Medium (UTM-RT) SystemJSMSubstantially EquivalentCopan Italia Spaaccessdata.fda.gov
September 17, 2020K201849eNAT molecular collection and preservation mediumQBDSubstantially EquivalentCopan Italia Spaaccessdata.fda.gov
March 23, 2018K180052UriSwab-Urine Collection, Transport and Preservation SystemJSMSubstantially EquivalentCopan Italia Spaaccessdata.fda.gov
April 10, 2015K142094COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEMJSMSubstantially EquivalentCopan Italia Spaaccessdata.fda.gov
May 25, 2012K121039COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEMJTWSubstantially EquivalentCopan Flock Technologiesaccessdata.fda.gov
December 11, 2008K081825BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAYLSLSubstantially EquivalentBecton, Dickinson & COaccessdata.fda.gov
June 23, 2006K061301COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEMJTWSubstantially EquivalentCopan Diagnostics, Inc.accessdata.fda.gov
December 7, 2004K042970COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEMJSMSubstantially EquivalentCopan Diagnostics, Inc.accessdata.fda.gov
July 31, 2001K001780COPAN VIRAL TRANSYSTEMJSMSubstantially EquivalentCopan Diagnostics, Inc.accessdata.fda.gov
November 9, 1999K993161COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEMJTWSubstantially EquivalentCopan Diagnostics, Inc.accessdata.fda.gov
August 20, 1997K972449COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOALJSLSubstantially EquivalentCopan Italia Spaaccessdata.fda.gov
August 20, 1997K972448COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOALJSLSubstantially EquivalentCopan Italia Spaaccessdata.fda.gov
March 10, 1995K946288COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUMJSMSubstantially EquivalentCopan Diagnostics, Inc.accessdata.fda.gov
March 10, 1995K946287COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOALJSMSubstantially EquivalentCopan Diagnostics, Inc.accessdata.fda.gov
March 10, 1995K946286COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUMJSMSubstantially EquivalentCopan Diagnostics, Inc.accessdata.fda.gov
March 10, 1995K946285COPAN VENTURI TRANSYSTEM STUARTS MEDIUMJSMSubstantially EquivalentCopan Diagnostics, Inc.accessdata.fda.gov
March 10, 1995K946284COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOALJSMSubstantially EquivalentCopan Diagnostics, Inc.accessdata.fda.gov
March 10, 1995K946283COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUMJSMSubstantially EquivalentCopan Diagnostics, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
October 29, 202597961Class IIOngoing1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) SystemTreatment reagent functionality in respiratory specimens liquification cannot be guaranteed.accessdata.fda.gov
May 2, 202596807Class IIOngoingBD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx OnlySwabs for specimen collection may be prone to breakage during product usage.accessdata.fda.gov
July 9, 202188437Class IITerminatedCOPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Minitip, sterile Single Wrapped, Molded bp 80mm; REF: 20226, P/N 501CS01Q100, Minitip, Sterile, Single WA sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano.accessdata.fda.gov
August 9, 201365923Class IIITerminatedWASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog number: W086 WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infeThe recall of the WASP (Walk Away Specimen Process) instrument was initiated because Copan Italia SpA has upgraded the software concerning the broth inoculation table feature. The upgrade has been considered necessary from the manufacturer in order to eliminate the very low risk of rotation of the broth table when the door is open.accessdata.fda.gov

Compare with other makers

Updated December 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.