FDA Registration
Active
🇲🇽 Mexico
Sensinel
Reg #: 3008255748
·
FEI: 3008255748
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HI-TECH PRODUCTS DE MEXICO S.A. DE C.V.
- Registration Number
- 3008255748
- FEI Number
- 3008255748
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Onda Helada 14903 int.4, Centro Industrial Las Brisas gas y Anexa
- City
- La Mesa, Tijuana Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K231086
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 |
|---|---|---|---|---|---|
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2024-09-09 |
Proprietary Names
Sensinel
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)