Data / Medical devices / France / Biomerieux SA
Biomerieux SA: FDA-registered device maker in Combourg Ille-et-Vilaine, France, 2 510(k) clearances
Biomerieux SA is registered with the FDA (registration 3013394941) in Combourg Ille-et-Vilaine, France. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 6, 2018. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013394941
- Address
- 4 bis, rue des Coutures, Combourg Ille-et-Vilaine, France, 35270
- Owner or operator
- BIOMERIEUX SA (8020790)
- Roles
- Manufacturer
- First device listed
- August 25, 1992
- Registered through
- 2027
- Brand names listed
- CHROMID CARBA agar (CARB), CHROMID Candida Agar, ChromID S. aureus Elite Agar, NTM Elite agar, chromID C. Difficile, chromID CARBA, chromID P. aeruginosa agar, chromID VRE Agar
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | JSO | 2 | Manufacturer | accessdata.fda.gov |
| Culture Media, Selective And Differential | JSI | 1 | Manufacturer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 6, 2018 | K181092 | CHROMID CARBA agar (CARB) | JSO | Substantially Equivalent | Biomerieux S.A. | accessdata.fda.gov |
| March 2, 2010 | K091025 | CHROMID VRE AGAR, MODEL: REF 43 851 | JSO | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
- All makers of Culture Media, Selective And Differential
Updated July 6, 2018. 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.