Data / Medical devices / Italy / BELLCO Srl
BELLCO Srl: FDA-registered device maker in Mirandola Modena, Italy, 2 510(k) clearances
BELLCO Srl is registered with the FDA (registration 1000312731) in Mirandola Modena, Italy. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 14, 2023. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1000312731
- Address
- via Camurana, 1, Mirandola Modena, Italy, 41037
- Owner or operator
- Bellco S.r.l. (10096547)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 19, 2026
- Registered through
- 2027
- Brand names listed
- Clearum HS 17, Clearum HS dialyzers, DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| June 14, 2023 | K231406 | ClearumTM HS | KDI | Substantially Equivalent | Bellco Srl | accessdata.fda.gov |
| October 8, 2020 | K193542 | Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 | KDI | Substantially Equivalent | Bellco Srl | accessdata.fda.gov |
Compare with other makers
Updated June 14, 2023. 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.