FDA Registration
Active
🇲🇽 Mexico
BWI Affinity Cable
Reg #: 3008093809
·
FEI: 3008093809
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FOXCONN BAJA CALIFORNIA S.A DE C.V.
- Registration Number
- 3008093809
- FEI Number
- 3008093809
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Laguna Mainar 5520. El lago Tijuana, Baja California 22210 Mexico
- City
- tijuana Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K113213
Owner / Operator
- Firm Name
- FOXCONN BAJA CALIFORNIA S.A DE C.V.
- Operator Number
- 10060158
- Address
- Laguna Mainar 5520. El Lago Tijuana, Baja California 22210 Mexico
- City
- Tijuana
- State
- Baja California
- Postal Code
- 22210
- Country
- MX
- Correspondent
- Francisco Lepe
US Agent
- Business Name
- KARA & Associates
- Contact Name
- Korina Akhondzadeh
- Address
- 6965 El Camino Real Suite 105-428
- City
- Carlsbad
- State
- CA
- ZIP
- 92009
- Country
- US
- [email protected]
- Phone
- 858 3448168
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2023-12-21 |
Proprietary Names
BWI Affinity Cable
BWI Lasso Nav
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)