Data / Medical devices / Italy / Copan WASP
Copan WASP: FDA-registered device maker in Brescia Lombardy, Italy, 2 510(k) clearances
Copan WASP is registered with the FDA (registration 3009288740) in Brescia Lombardy, Italy. It lists 14 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 22, 2026. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3009288740
- Address
- Via Achille Grandi, 32, Brescia Lombardy, Italy, 25125
- Owner or operator
- COPAN ITALIA Spa (9016900)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 27, 1995
- Registered through
- 2026
- Brand names listed
- BD Inoculation Loops, Colibri, Colibri Daily Verification Kit, Colibri Primary Tube for Vitek 2, Colibri Primary Tube with Saline, Colibri Primary Tube with Water, Colibri Spreader, Collaborative Station and more
Devices it lists
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 22, 2026 | K251511 | PhenoMATRIX | PPU | Substantially Equivalent | Copan Wasp Srl | accessdata.fda.gov |
| December 27, 2023 | K232756 | Colibrí | LON | Substantially Equivalent | Copan Wasp Srl | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 16, 2026 | 99302 | Class II | Ongoing | Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1, 2.33.3 and 2.34.2 Product Description: WASPLab is an automated device intended to be used for the incubation a | Due to a software issue within the WebApp that potentially prevents the user to overwrite the results. | accessdata.fda.gov |
| May 6, 2025 | 96765 | Class II | Ongoing | PhenoMATRIX | AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology information from images may not accurately reflect actual plate and may lead to inaccurate counts and/or morphology characteristics impacting pat | accessdata.fda.gov |
Compare with other makers
- All makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- All makers of Station, Pipetting And Diluting, For Clinical Use
- All makers of Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
- All makers of Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
- All makers of System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- All makers of Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
Updated July 31, 2026. 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.