Data / Medical devices / Mexico / Fresenius Medical Care de Mexico
Fresenius Medical Care de Mexico: FDA-registered device maker in Zapopan Jalisco, Mexico, 2 510(k) clearances
Fresenius Medical Care de Mexico is registered with the FDA (registration 3012364195) in Zapopan Jalisco, Mexico. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 9, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012364195
- Address
- Paseo del Norte No. 5300, Zapopan Jalisco, Mexico, 45010
- Owner or operator
- Fresenius Medical Care Renal Therapies Group, LLC (9030510)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 31, 2024
- Registered through
- 2026
- Brand names listed
- Bicarby Dialysate
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | 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 |
|---|---|---|---|---|---|---|
| September 9, 2025 | K252180 | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W) | KPO | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| April 4, 2025 | K243786 | Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G) | KPO | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
Compare with other makers
Updated September 9, 2025. 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.