ERIKA DE REYNOSA, S.A. DE C.V.

FDA Device Registration & Listing · CD, REYNOSA Tamaulipas, MX · Registration 8030665

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8030665
FEI Number
3002807744
Entity Name
ERIKA DE REYNOSA, S.A. DE C.V.
City/State/Country
CD, REYNOSA Tamaulipas, MX
Establishment Address
MIKE ALLEN 1331, 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
N
Expiration Date (Year)
2026
510(k) Number
K124024
PMA Number
N/A

All Registered Proprietary Names

5008X CAREsystem Crit-Line Clip (CLiC) Blood Chamber Combilines Hemodialysis Blood Tubing Set Fresenius Combilines Single Needle Blood Tubing Set stay•safe Catheter Extension Sets 4 LEAD ECO PREFILLED W/SNAP DISCONNECT Safe-Lock Universal Connector Fresenius BVM Hemodialysis Blood Tubing Set with Priming Set CATHETER ADAPTER SEALING CAP Liberty Drain Line Combiset Blood Line 2008K@HOME HEMODIALYSIS MACHINE CombiSet - 2008 Series Home Hemodialysis with Prime Bag Cycler Drain Bag Set Transducer Protectors Fresenius Priming Set with Needless Access Port CombiSet SMARTECH Hemodialysis Blood Tubing Sets Fresenius Sterile Stay Safe Cap stay safe Drain Set Multiple Tubing Segment (MTS) Set with stay safe PIN Connectors Safe-Lock catheter adapter Co-Pack II Liberty Cycler Set StaySafe Handi-Tool StaySafe Organizer StaySafe Clip StaySafe Organizer Holder APD Luer Lock Adapter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2025-06-03
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2025-06-03
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2025-06-03
NII Disinfectant, Dialysate Delivery System Gastroenterology, Urology Class 2 876.5860 2025-06-03
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2025-06-03
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2016-01-26
FKX System, Peritoneal, Automatic Delivery Gastroenterology, Urology Class 2 876.5630 2014-08-20
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2008-03-05
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2008-01-08
KDJ Set, Administration, For Peritoneal Dialysis, Disposable Gastroenterology, Urology Class 2 876.5630 2025-09-10
FKX System, Peritoneal, Automatic Delivery Gastroenterology, Urology Class 2 876.5630 2009-07-16
KDJ Set, Administration, For Peritoneal Dialysis, Disposable Gastroenterology, Urology Class 2 876.5630 2015-06-25
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2012-06-27
FKX System, Peritoneal, Automatic Delivery Gastroenterology, Urology Class 2 876.5630 2009-07-16
FKX System, Peritoneal, Automatic Delivery Gastroenterology, Urology Class 2 876.5630 2008-01-08
ONW Hemodialysis System For Home Use Gastroenterology, Urology Class 2 876.5860 2017-02-17
ODX Autonomous Extracorporeal Blood Leak Detector/Alarm Gastroenterology, Urology Class 2 876.5820 2011-05-04
ONW Hemodialysis System For Home Use Gastroenterology, Urology Class 2 876.5860 2011-05-04
KDJ Set, Administration, For Peritoneal Dialysis, Disposable Gastroenterology, Urology Class 2 876.5630 2018-01-26
FIB Protector, Transducer, Dialysis Gastroenterology, Urology Class 2 876.5820 2008-01-08
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2008-01-08
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2020-09-22
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2020-09-22
KDJ Set, Administration, For Peritoneal Dialysis, Disposable Gastroenterology, Urology Class 2 876.5630 2008-12-30
KDJ Set, Administration, For Peritoneal Dialysis, Disposable Gastroenterology, Urology Class 2 876.5630 2018-02-15
FKX System, Peritoneal, Automatic Delivery Gastroenterology, Urology Class 2 876.5630 2009-07-16
FKX System, Peritoneal, Automatic Delivery Gastroenterology, Urology Class 2 876.5630 2018-05-15
KDJ Set, Administration, For Peritoneal Dialysis, Disposable Gastroenterology, Urology Class 2 876.5630 2015-02-27

Official Correspondent

Rachel Lloyd

US Agent Details

Denise Oppermann Business: Fresenius Medical Care North America Email: denise.m.oppermann@freseniusmedicalcare.com Phone: (781) 6994479

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
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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K110578 Mar Cor Purification, Inc. MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM 2011-05-20
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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-05 Ameriwater Inc 2
AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030665. Last updated year: 2026. Please use registration number 8030665 when referencing this establishment in official correspondence.
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