Data / Medical devices / France / Medwin France
Medwin France: FDA-registered device maker in Les Aires Herault, France, 1 510(k) clearance
Medwin France is registered with the FDA (registration 3013788631) in Les Aires Herault, France. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 9, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013788631
- Address
- 9, allee de la Vigne Grande, Les Aires Herault, France, 34600
- Owner or operator
- MEDWIN France (10079804)
- Roles
- Contract manufacturer, Specification developer
- First device listed
- January 7, 2021
- Registered through
- 2026
- Brand names listed
- Nutrisafe2, PILOT TLS, PUGGLE® Enteral Feeding Pump
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | 2 | Contract manufacturer | accessdata.fda.gov |
| Enteral Specific Transition Connectors | PIO | 2 | Specification developer | accessdata.fda.gov |
| Pump, Infusion, Enteral | LZH | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| February 9, 2016 | K151237 | Nutrisafe 2- ENFit Adaptor | PIO | Substantially Equivalent | Vygon | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Infusion, Enteral
- All makers of Enteral Specific Transition Connectors
- All makers of Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Updated February 9, 2016. 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.