Data / Medical devices / Mexico / Erika de Reynosa, S.A. de C.V.
Erika de Reynosa, S.A. de C.V.: FDA-registered device maker in CD, Reynosa Tamaulipas, Mexico, 4 510(k) clearances
Erika de Reynosa, S.A. de C.V. is registered with the FDA (registration 3031565407) in CD, Reynosa Tamaulipas, Mexico. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 13, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031565407
- Address
- Mike Allen 1392, Parque Industrial Reynosa, CD, Reynosa Tamaulipas, Mexico, 88780
- Owner or operator
- Fresenius Medical Care Renal Therapies Group, LLC (9030510)
- Roles
- Manufacturer
- First device listed
- August 7, 2014
- Registered through
- 2026
- Brand names listed
- 2008T BlueStar Hemodialysis Machine, Liberty Select Cycler
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 2 | Manufacturer | accessdata.fda.gov |
| System, Peritoneal, Automatic Delivery | FKX | 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 |
|---|---|---|---|---|---|---|
| June 13, 2025 | K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130) | KDI | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| December 6, 2023 | K231125 | 2008T BlueStar Hemodialysis Machine | KDI | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| October 31, 2022 | K222318 | Fresenius Liberty Select Cycler | FKX | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| July 7, 2014 | K133299 | ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY | KDI | Substantially Equivalent | Fresenius Medical Care, North America - Renal Ther | accessdata.fda.gov |
Compare with other makers
- All makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System
- All makers of System, Peritoneal, Automatic Delivery
Updated June 13, 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.