Data / Medical devices / Italy / GVS SPA
GVS SPA: FDA-registered device maker in Borgocarbonara Mantova, Italy, 1 510(k) clearance
GVS SPA is registered with the FDA (registration 9614854) in Borgocarbonara Mantova, Italy. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 19, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9614854
- FEI number
- 3003824461
- Address
- Via Ugo Roncada 83/E, Borgocarbonara Mantova, Italy, 46020
- Owner or operator
- GVS SPA (10094933)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 7, 2026
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, I.V. | KPE | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 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 |
|---|---|---|---|---|---|---|
| August 19, 2021 | K210749 | Empty EVA Bag | KPE | Substantially Equivalent | Haemotronic S.P.A. | accessdata.fda.gov |
Compare with other makers
Updated August 19, 2021. 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.