Data / Medical devices / Mexico / Renal Care Dialysis Solutions, S.A. De C.V.
Renal Care Dialysis Solutions, S.A. De C.V.: FDA-registered device maker in El Marques Queretaro, Mexico, 1 510(k) clearance
Renal Care Dialysis Solutions, S.A. De C.V. is registered with the FDA (registration 3027241826) in El Marques Queretaro, Mexico. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 3, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3027241826
- Address
- Carretera a los Cues K.M. 2.2, Lote 23 Bodegas 5 y 6., El Marques Queretaro, Mexico, 76246
- Owner or operator
- RENAL CARE DIALYSIS SOLUTIONS, S.A. DE C.V. (10087843)
- Roles
- Manufacturer
- First device listed
- April 18, 2023
- Registered through
- 2026
- Brand names listed
- NIKKICART
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | 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 |
|---|---|---|---|---|---|---|
| March 3, 2023 | K221652 | NIKKICART | KPO | Substantially Equivalent | Renal Care Dialysis Solutions, S.A. DE C.V. | accessdata.fda.gov |
Compare with other makers
Updated March 3, 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.