Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008692839

FEI Number

3008692839

Entity Name

RM Healthcare Products SA de CV

City/State/Country

JUAREZ Chihuahua, MX

Establishment Address

PARQUE INDUSTRIAL ANTONIO J., BERMUDEZ CALLE FRESNEL 8375, JUAREZ Chihuahua 32470, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Medicar Health Inc. (Owner Number: 10043820)

Owner / Operator Contact Address

303N. Oregon ste 230, El Paso, TX 79901, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Walkmed Infusion LLC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2021-12-23
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2013-06-27
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2013-06-25
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2013-06-27
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2013-06-25
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	2013-07-16
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2014-12-08
LXP	Plug, Scleral	Ophthalmic	Class 2	886.4155	2013-07-08
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2013-06-27
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2021-12-23
HQR	Apparatus, Cautery, Radiofrequency, Ac-Powered	Ophthalmic	Class 2	886.4100	2013-06-27
MLZ	Vitrectomy, Instrument Cutter	Ophthalmic	Class 2	886.4150	2013-06-27
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2013-06-27
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2013-06-18
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2013-06-27
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2013-06-25

Official Correspondent

Hector Palacios

US Agent Details

Hector Palacios Email: said.medina25@gmail.com Phone: (915) 5198804

Related Public Records

Same Entity

Medicar Health 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
3029973819	MANUFACTURAS Y SERVICIOS INTERNACIONALES, S. DE R.L.	Cd Juarez Chihuahua, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K091915	Lenstec, Inc.	FLUID ISOLATION DEVICE	2009-10-27
K830812	Alphamedix, Inc.	ALPHAMEDIX I/A HAND-PIECE, 500-001	1983-06-08
K133115	Abbott Medical Optics, Inc.	COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK	2014-02-27
K121721	Abbott Medical Optics, Inc.	LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)	2012-10-15
K111697	Abbott Medical Optics, Inc.	AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM	2011-09-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2008	Lemaitre Vascular, Inc.	2	CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05	Medrad Inc	2	Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT
Z-1670-2013	Abbott Medical Optics, Inc.	2	Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Z-0099-2024	Alcon Research, LLC	2	Constellation Vision System, REF: 8065751150
Z-0305-2026	Alcon Research LLC	2	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUMATOR,RFID,23G 8065751014 CONST AUTO GAS FILL PAK 8065751014 CONST AUTO GAS FILL PAK 8065751441 ENDOILLUMINATOR,RFID,25G 8065751577 CHANDELIER,25GA,W/RFID Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008692839. Last updated year: 2026. Please use registration number 3008692839 when referencing this establishment in official correspondence.