Data / Medical devices / Italy / Haemopharm Biofluids SRL
Haemopharm Biofluids SRL: FDA-registered device maker in Tovo di S.Agata Sondrio, Italy, 1 510(k) clearance
Haemopharm Biofluids SRL is registered with the FDA (registration 3010242164) in Tovo di S.Agata Sondrio, Italy. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 23, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010242164
- Address
- via Industria 6, Tovo di S.Agata Sondrio, Italy, 23030
- Owner or operator
- Haemopharm Biofluids (10095692)
- Roles
- Manufacturer
- First device listed
- April 15, 2026
- Registered through
- 2026
- Brand names listed
- HMB32 Dialysis Solution
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 |
|---|---|---|---|---|---|---|
| July 23, 2021 | K212052 | HMB32 Dialysis Solution | KPO | Substantially Equivalent | Haemopharm Biofluids S.R.L. | accessdata.fda.gov |
Compare with other makers
Updated July 23, 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.