Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616074

FEI Number

3002654698

Entity Name

MEDIMEXICO, S. DE R.L. DE C.V.

City/State/Country

TIJUANA Baja California, MX

Establishment Address

AV. VALLE IMPERIAL NO. 10523, PARQUE INDUSTRIAL VALLE SUR, TIJUANA Baja California 22180, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Fresenius Medical Care Holdings, Inc. (Owner Number: 10061218)

Owner / Operator Contact Address

920 Winter Street, Waltham, MA 02451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VersiHD with GuideMe Software ViraGuard Viral Blocking Patient Transducer Protector

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FKR	Subsystem, Proportioning	Gastroenterology, Urology	Class 2	876.5820	2019-09-25
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2019-09-25
FKR	Subsystem, Proportioning	Gastroenterology, Urology	Class 2	876.5820	2019-09-25
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2019-09-25
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	Class 2	876.5820	2019-09-25
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2023-08-15
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-09-25
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	Class 2	876.5820	2019-09-25
FIB	Protector, Transducer, Dialysis	Gastroenterology, Urology	Class 2	876.5820	2019-09-25
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2024-05-08
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2019-09-25
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2019-09-25
FLA	Monitor, Temperature, Dialysis	Gastroenterology, Urology	Class 2	876.5820	2019-09-25

Official Correspondent

Rachel Lloyd

US Agent Details

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

Related Public Records

Same Entity

Fresenius Medical Care Holdings, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003464075	NXSTAGE MEDICAL, INC.	LAWRENCE, MA, 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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
Z-0007-2024	Fresenius Medical Care Holdings, Inc.	2	3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
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

Similar Registrations

Registration Number	Establishment Name	Location
1649518	Sterigenics US LLC	Fort Worth, TX, US
3003464075	NXSTAGE MEDICAL, INC.	LAWRENCE, MA, US
3015349756	DIALITY, INC.	Irvine, CA, US
9611824	FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH	SCHWEINFURT Bavaria, DE
3012149633	LIDER	MONTREVEL EN BRESSE Auvergne-Rhone-Alpes, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616074. Last updated year: 2026. Please use registration number 9616074 when referencing this establishment in official correspondence.