FDA Registration
Active
🇲🇽 Mexico
HI-TECH PRODUCTS DE MEXICO S.A. DE C.V.
Reg #: 3008255748
·
FEI: 3008255748
·
Expires 2026
Products
20
Proprietary Names
26
Establishment Types
1
Classifications
20
Registration Details
- Registration Name
- HI-TECH PRODUCTS DE MEXICO S.A. DE C.V.
- Registration Number
- 3008255748
- FEI Number
- 3008255748
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Onda Helada 14903 int.4, Centro Industrial Las Brisas gas y Anexa
- City
- La Mesa, Tijuana Baja California
- Country
- MX
Owner / Operator
- Firm Name
- Hi-Tech Products de Mexico S.A. de C.V.
- Operator Number
- 10052098
- Address
- Onda Helada 14903 int.4, Centro Industrial Las Brisas gas y Anexa
- City
- La Mesa, Tijuana
- State
- Baja California
- Postal Code
- 22115
- Country
- MX
US Agent
- Business Name
- Hi-Tech Labels
- Contact Name
- Damian Craig
- Address
- 8530 Roland St
- City
- Buena Park
- State
- CA
- ZIP
- 90621
- Country
- US
- [email protected]
- Phone
- 714 6702150
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reduced- Montage Standard Electroencephalograph | OMC | Class 2 | Neurology | No | 2025-05-01 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2025-05-01 |
| Percutaneous Nerve Stimulator For Opioid Withdrawal | PZR | Class 2 | Neurology | No | 2021-06-08 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2022-05-18 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2023-02-20 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2024-01-22 |
| Light, Ultraviolet, Dermatological | FTC | Class 2 | General, Plastic Surgery | No | 2018-06-07 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2024-09-09 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2017-12-15 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2025-12-18 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2022-04-21 |
| Stimulator, Spinal-Cord, Implanted (Pain Relief) | GZB | Class 2 | Neurology | No | 2025-12-18 |
| Stimulator, Peripheral Nerve, Implanted (Pain Relief) | GZF | Class 2 | Neurology | No | 2025-12-18 |
| Dilator, Nasal | LWF | Class 1 | Ear, Nose, Throat | No | 2025-07-22 |
| System, Skin Closure | MKY | Class 1 | General, Plastic Surgery | No | 2022-11-18 |
| Chamber, Oxygen, Topical, Extremity | KPJ | Class 2 | General, Plastic Surgery | No | 2018-05-22 |
| Retention Device, Suture | KGS | Class 1 | General, Plastic Surgery | No | 2022-09-08 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2020-04-03 |
| External Urethral Occluder, Urinary Incontinence-Control, Female | MNG | Class 1 | Gastroenterology, Urology | No | 2018-06-07 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2016-06-13 |
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
Finess
Moxy Patch
Sotera Wireless, Inc.
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)