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
Phone
707 4810011

Products

Device Name Product Code
Implant, Cochlear MCM

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