Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008255748

FEI Number

3008255748

Entity Name

HI-TECH PRODUCTS DE MEXICO S.A. DE C.V.

City/State/Country

La Mesa, Tijuana Baja California, MX

Establishment Address

Onda Helada 14903 int.4, Centro Industrial Las Brisas gas y Anexa, La Mesa, Tijuana Baja California 22115, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Hi-Tech Products de Mexico S.A. de C.V. (Owner Number: 10052098)

Owner / Operator Contact Address

Onda Helada 14903 int.4, Centro Industrial Las Brisas gas y Anexa, La Mesa, Tijuana, MX-BCN 22115, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

REMI Sparrow Therapy System Skin Grip XSTAT Taurus Eyelid Patch Exciplex Silicone Mask Sensinel Bikini Zone Acnedote Pimple Patches PanOxyl PM Spot Patch MaxSkin Spot Sucker Goodline Ingrown Hair and Neck Patch Off Bite Patch FASTBreathe Thoracic Seal (FTS) FAST Combat Wound Seal (CWS)6 BioButton Rechargeable Adhesive NeoGuard Thermal Reflector Cold Seal BioButton Rechargable Adhesive Nalu Clip Pack InTake Nasal Dialator Hemigard Oxy Spur Suturegard

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2025-05-01
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2025-05-01
PZR	Percutaneous Nerve Stimulator For Opioid Withdrawal	Neurology	Class 2	882.5896	2021-06-08
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2022-05-18
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2023-02-20
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2024-01-22
FTC	Light, Ultraviolet, Dermatological	General, Plastic Surgery	Class 2	878.4630	2018-06-07
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2024-09-09
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2017-12-15
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2025-12-18
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2022-04-21
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2025-12-18
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	Neurology	Class 2	882.5870	2025-12-18
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2025-07-22
MKY	System, Skin Closure	General, Plastic Surgery	Class 1	878.4320	2022-11-18
KPJ	Chamber, Oxygen, Topical, Extremity	General, Plastic Surgery	Class 2	878.5650	2018-05-22
KGS	Retention Device, Suture	General, Plastic Surgery	Class 1	878.4930	2022-09-08

Official Correspondent

No official correspondent registered.

US Agent Details

Damian Craig Business: Hi-Tech Labels Email: dcraig@hi-tech-products.com Phone: (714) 6702150

Related Public Records

Same Entity

Hi-Tech Products de Mexico S.A. de C.V.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2015	Invivo Corporation	2	Philips Expression MR200 MRI Patient Monitoring System Model 866120
Z-0004-2023	Philips North America Llc	2	MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Z-0011-04	GE Medical Systems Information Technologies	2	Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug.
Z-0042-2015	Mckesson Information Solutions LLC	2	McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Z-2183-2011	Remote Diagnostic Technologies Ltd. The Old Coach House, The Av. Farleigh Wallop, Basingstoke Hampshire United Kingdom	2	TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT. Indicated for 3 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal C02 (ETCO 2), pulse oximetry (SP02) and tympanic temperature.

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3009156722	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.	Shenzhen Guangdong, CN
3010611950	Natus Neurology Incorporated	Middleton, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008255748. Last updated year: 2026. Please use registration number 3008255748 when referencing this establishment in official correspondence.