Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031565407

FEI Number

3031565407

Entity Name

Erika de Reynosa, S.A. de C.V.

City/State/Country

CD, Reynosa Tamaulipas, MX

Establishment Address

Mike Allen 1392, Parque Industrial Reynosa, CD, Reynosa Tamaulipas 88780, 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

K222318

PMA Number

N/A

All Registered Proprietary Names

2008T BlueStar Hemodialysis Machine Liberty Select Cycler

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2024-02-15
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2023-01-30

Official Correspondent

Rachel Lloyd

US Agent Details

Denise Oppermann Business: FRESENIUS MEDICAL CARE NORTH AMERICA Email: Denise.M.Oppermann@freseniusmedicalcare.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
3012364195	Fresenius Medical Care de Mexico	Zapopan Jalisco, 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

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K811830	Cordis Corp.	C-DAK DUO-FLUX ARTIFICIAL KIDNEY	1981-09-21
K070320	Edwards Lifesciences Services GmbH	EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01	2007-06-07
K150880	Outset Medical	Tablo Console with Wireless Capability	2015-05-01
K822361	Travenol Laboratories, S.A.	DIANEAL SOLUTION EXCHANGE DEVICE #5C4193	1982-08-16
K933687	R & D Batteries, Inc.	R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260	1994-02-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0019-2025	Outset Medical, Inc.	2	Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
Z-0028-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis SYS, with CDX
Z-0029-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis System without CDX
Z-0030-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis System w/Bibag
Z-0031-2024	Fresenius Medical Care Holdings, Inc.	2	2008T GEN 2 Bibag without CDX

Similar Registrations

Registration Number	Establishment Name	Location
3015349756	DIALITY, INC.	Irvine, CA, US
9611824	FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH	SCHWEINFURT Bavaria, DE
3012149633	LIDER	MONTREVEL EN BRESSE Auvergne-Rhone-Alpes, FR
3005695808	SARMED SRL	IGLESIAS Sardegna, IT
3007137787	Nuwellis, Inc.	Eden Prairie, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031565407. Last updated year: 2026. Please use registration number 3031565407 when referencing this establishment in official correspondence.