Data / Medical devices / France / Medex
Medex: FDA-registered device maker in SAINT-PRIEST Auvergne-Rhone-Alpes, France, 2 510(k) clearances
Medex is registered with the FDA (registration 3012261967) in SAINT-PRIEST Auvergne-Rhone-Alpes, France. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 29, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012261967
- Address
- 240 Allee Jacques Monod, SAINT-PRIEST Auvergne-Rhone-Alpes, France, 69800
- Owner or operator
- Guerbet LLC / Liebel-Flarsheim Company LLC (10050387)
- Roles
- Manufacturer, Specification developer
- First device listed
- June 17, 2022
- Registered through
- 2026
- Brand names listed
- Qitexio 4-Way Stopcock, Qitexio Luer Lock Syringes
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stopcock, I.V. Set | FMG | 2 | Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | 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 |
|---|---|---|---|---|---|---|
| April 29, 2025 | K242255 | Qitexio® 4-Way Stopcock (QIT014) | FMG | Substantially Equivalent | Medex | accessdata.fda.gov |
| March 14, 2022 | K203738 | Qitexio | FMF | Substantially Equivalent | Medex | accessdata.fda.gov |
Compare with other makers
Updated April 29, 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.