Data / Medical devices / Dialyzer, High Permeability With Or Without Sealed Dialysate System / Mexico
FDA-registered makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System in Mexico: 7 establishments
7 establishments in Mexico 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 3, 2026.
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- Device
- Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Product code
- KDI
- Country
- Mexico
Makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System in Mexico
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Baja Fur S.A. de C.V. | Tijuana BC. Baja California, Mexico | Specification developer | 7 | January 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| Baja Fur S.A. de C.V. | Tijuana Baja California, Mexico | Manufacturer | 6 | January 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| Erika de Reynosa, S.A. de C.V. | CD, Reynosa Tamaulipas, Mexico | Manufacturer | 3 | June 13, 2025 | 0 | 0 | 0 | api.fda.gov |
| Erika De Reynosa, S.A. De C.V. | CD, REYNOSA Tamaulipas, Mexico | Manufacturer | 2 | May 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Erika De Reynosa, S.A. De C.V. | CD, REYNOSA Tamaulipas, Mexico | Manufacturer | 1 | May 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| AvailMed S.A.De C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medimexico, S. De R.L. De C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.