FDA Registration
Active
🇲🇽 Mexico
Philips Medical
Reg #: 3005677568
·
FEI: 3005677568
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- VOLEX DE MEXICO
- Registration Number
- 3005677568
- FEI Number
- 3005677568
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Av. 32 Sur ,No.8950,
- City
- TIJUANA Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K203231
Owner / Operator
- Firm Name
- VOLEX DE MEXICO
- Operator Number
- 10047420
- Address
- Av. 32 Sur ,No.8950,
- City
- TIJUANA
- State
- Baja California
- Postal Code
- 22116
- Country
- MX
- Correspondent
- Mona Luchene
US Agent
- Business Name
- Volex Inc.
- Contact Name
- Mona Luchene Luchene
- Address
- 9355 Airway Road Suite#4
- City
- San Diego
- State
- CA
- ZIP
- 92154
- Country
- US
- [email protected]
- Phone
- 630 7283483
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dc-Defibrillator, Low-Energy, (Including Paddles) | LDD | Class 2 | Cardiovascular | No | 2025-04-01 |
Proprietary Names
Philips Medical
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)