FDA Registration
Active
🇲🇽 Mexico
Sky CI M90 Sound Processor
Reg #: 3030784382
·
FEI: 3030784382
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Advanced Bionics North American Operations Center S.A. de C.V.
- Registration Number
- 3030784382
- FEI Number
- 3030784382
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Avenida Riba 875, Parque Industrial Condesa
- City
- Mexicali Baja California
- Country
- MX
Regulatory Submissions
- PMA Number
- P960058
Owner / Operator
- Firm Name
- Advanced Bionics LLC
- Operator Number
- 10023794
- Address
- 28515 Westinghouse Place
- City
- Valencia
- State
- CA
- Postal Code
- 91355
- Country
- US
US Agent
- Business Name
- ADVANCED BIONICS LLC
- Contact Name
- Michelle Caulfield
- Address
- 28515 Westinghouse Place
- City
- Valencia
- State
- CA
- ZIP
- 91355
- Country
- US
- [email protected]
- Phone
- 707 4810011
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Cochlear | MCM | Class 3 | Unknown | No | 2007-12-14 |
Proprietary Names
Sky CI M90 Sound Processor
Naida CI Q90
Naida CI M30 Sound Processor
CLARION CII BIONIC EAR
HIRESOLUTION BIONIC EAR SYSTEM
Naida CI M90 Sound Processor
Naida CI Q30
Naida CI Q70
Establishment Types
Manufacture Medical Device