Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030784382

FEI Number

3030784382

Entity Name

Advanced Bionics North American Operations Center S.A. de C.V.

City/State/Country

Mexicali Baja California, MX

Establishment Address

Avenida Riba 875, Parque Industrial Condesa, Mexicali Baja California 21395, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Advanced Bionics LLC (Owner Number: 10023794)

Owner / Operator Contact Address

28515 Westinghouse Place, Valencia, CA 91355, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P960058

All Registered Proprietary Names

CLARION CII BIONIC EAR HIRESOLUTION BIONIC EAR SYSTEM Sky CI M90 Sound Processor Naida CI M90 Sound Processor Naida CI Q90 Naida CI Q70 Naida CI M30 Sound Processor Naida CI Q30

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MCM	Implant, Cochlear	Unknown	Class 3	N/A	2007-12-14

Official Correspondent

No official correspondent registered.

US Agent Details

Michelle Caulfield Business: Advanced Bionics LLC Email: Michelle.Caulfield@advancedbionics.com Phone: (707) 4810011

Related Public Records

Same Entity

Advanced Bionics LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009762645	Advanced Bionics LLC	Valencia, CA, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2012	Cochlear Americas Inc.	3	Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia. The cochlear implant is intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve.
Z-0044-05	Advanced Bionics	3	Advanced Bionics implantable cochlear stimulator CLARION 1.2 Models AB-5100L AB-5100R AB-5100ML/R (For Export Only) AB-5100H AB-5100H-01A

Similar Registrations

Registration Number	Establishment Name	Location
3009762645	Advanced Bionics LLC	Valencia, CA, US
9611813	CHRISTIAN DIENER GMBH	TUTTLINGEN Baden-Wurttemberg, DE
3013177549	Cochlear Malaysia Sdn Bhd	Kuala Lumpur Kuala Lumpur, MY
3009092818	Cochlear Ltd	Macquarie University New South Wales, AU
9613646	Cochlear Limited - Brisbane	Newstead Queensland, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030784382. Last updated year: 2026. Please use registration number 3030784382 when referencing this establishment in official correspondence.