Data / Medical devices / France / Technoflex SAS
Technoflex SAS: FDA-registered device maker in BIDART Nouvelle-Aquitaine, France, 1 510(k) clearance
Technoflex SAS is registered with the FDA (registration 3039404452) in BIDART Nouvelle-Aquitaine, France. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 18, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3039404452
- Address
- 69 ZA deBassilour, BIDART Nouvelle-Aquitaine, France, 64210
- Owner or operator
- TECHNOFLEX SAS (10093662)
- Roles
- Manufacturer
- First device listed
- June 18, 2025
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, I.V. | KPE | 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 18, 2025 | K250459 | DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution | KPE | Substantially Equivalent | Technoflex Sas. | accessdata.fda.gov |
Compare with other makers
Updated April 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.