Data / Medical devices / Italy / Valmed SRL
Valmed SRL: FDA-registered device maker in Tovo di S.Agata Sondrio, Italy, 2 510(k) clearances
Valmed SRL is registered with the FDA (registration 3009128476) in Tovo di S.Agata Sondrio, Italy. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 15, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009128476
- Address
- Via dell Industria 3, Tovo di S.Agata Sondrio, Italy, 23030
- Owner or operator
- Valmed Srl (10036141)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 21, 2011
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, I.V. | KPE | 2 | Manufacturer | accessdata.fda.gov |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 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 15, 2019 | K181393 | Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP | KPE | Substantially Equivalent | Valmed S.R.L. | accessdata.fda.gov |
| April 13, 2011 | K101412 | EVA TPN BAG | KPE | Substantially Equivalent | Valmed S.R.L. | accessdata.fda.gov |
Compare with other makers
- All makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System
- All makers of Container, I.V.
Updated February 15, 2019. 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.