Data / Medical devices / Dialyzer, High Permeability With Or Without Sealed Dialysate System / Italy
FDA-registered makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System in Italy: 7 establishments
7 establishments in Italy are registered with the FDA to make Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Product code
- KDI
- Country
- Italy
Makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System in Italy
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medica S.p.A. | Medolla Modena, Italy | Complaint file establishment, Specification developer | 7 | February 7, 2024 | 0 | 0 | 0 | api.fda.gov |
| Gambro Dasco S.P.A., Monitors Division | MEDOLLA Modena, Italy | Manufacturer | 4 | August 1, 2025 | 0 | 0 | 0 | api.fda.gov |
| Sorin Group Italia S.R.L | MIRANDOLA Modena, Italy | Manufacturer | 3 | April 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| BELLCO Srl | Mirandola Modena, Italy | Contract manufacturer, Manufacturer | 2 | June 14, 2023 | 0 | 0 | 0 | api.fda.gov |
| Gambro Dasco S.P.A., Blood Line Division | MEDOLLA Modena, Italy | Manufacturer, Specification developer | 2 | September 14, 2023 | 0 | 0 | 0 | api.fda.gov |
| Sarmed SRL | IGLESIAS Sardegna, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Valmed SRL | Tovo di S.Agata Sondrio, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.