Data / Medical devices / Italy / Bieffe Medital S.p.A.
Bieffe Medital S.p.A.: FDA-registered device maker in SONDALO (SO) Sondrio, Italy, 2 510(k) clearances
Bieffe Medital S.p.A. is registered with the FDA (registration 3003591774) in SONDALO (SO) Sondrio, Italy. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated January 6, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003591774
- Address
- Via Stelvio 94, SONDALO (SO) Sondrio, Italy, 23035
- Owner or operator
- Vantive US Healthcare LLC (9038727)
- Roles
- Manufacturer
- First device listed
- May 18, 2008
- Registered through
- 2026
- Brand names listed
- PRISMASATE, PrismaSATE dialysis solutions
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | 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 |
|---|---|---|---|---|---|---|
| January 6, 2017 | K162887 | PrismaSATE | KPO | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| February 4, 2008 | K072908 | PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY | KPO | Substantially Equivalent | Gambro Renal Products | accessdata.fda.gov |
Compare with other makers
Updated January 6, 2017. 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.