Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012364195

FEI Number

3012364195

Entity Name

Fresenius Medical Care de Mexico

City/State/Country

Zapopan Jalisco, MX

Establishment Address

Paseo del Norte No. 5300, Zapopan Jalisco 45010, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fresenius Medical Care Renal Therapies Group, LLC (Owner Number: 9030510)

Owner / Operator Contact Address

920 WINTER STREET, --, Waltham, MA 02451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252180

PMA Number

N/A

All Registered Proprietary Names

Bicarby Dialysate Bicarby Dialysate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2025-04-16
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2024-01-31
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2025-11-26

Official Correspondent

Rachel Lloyd

US Agent Details

DENISE OPPERMANN Business: Fresenius Medical Care North America Email: denise.m.oppermann@fmc-na.com Phone: (781) 9969103

Related Public Records

Same Entity

Fresenius Medical Care Renal Therapies Group, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3023981687	Erika of Texas	Pharr, TX, US
3031565407	Erika de Reynosa, S.A. de C.V.	CD, Reynosa Tamaulipas, MX
3005578748	Haemotec, a division of Fresenius Medical Care Canada Inc.	VAUDREUIL-DORION Quebec, CA
3013546115	Fresenius USA Manufacturing, Inc.	Knoxville, TN, US
3005162618	Fresenius USA Manufacturing, Inc.	OREGON, OH, US

Similar Registrations

Registration Number	Establishment Name	Location
2431908	EDLAW PHARMACEUTICALS, INC.	E Farmingdale, NY, US
9616277	S.M.A.D.	L'ARBRESLE Rhone, FR
3027241826	RENAL CARE DIALYSIS SOLUTIONS, S.A. DE C.V.	El Marques Queretaro, MX
1225714	Fresenius Medical Care Renal Therapies Group, LLC	Waltham, MA, US
1528807	Nipro Renal Solutions USA, Corporation	LEWISBERRY, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012364195. Last updated year: 2026. Please use registration number 3012364195 when referencing this establishment in official correspondence.