Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002806740

FEI Number

3002806740

Entity Name

COCHLEAR LTD.

City/State/Country

LANE COVE New South Wales, AU

Establishment Address

14 MARS ROAD, LANE COVE New South Wales 2066, AU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

COCHLEAR AMERICAS (Owner Number: 9076254)

Owner / Operator Contact Address

10350 Park Meadows Drive, Lone Tree, CO 80124, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

N22 COCHLEAR IMPLANT SYS FOR ADULTS Nucleus Auditory Brainstem Implant System ENT Surgical N22 COCHLEAR IMPLANT SYS FOR PED 7M Magnet for CP1000 5(I) Coils

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SEM	Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring	Neurology	Class 2	882.1360	2025-07-30
MCM	Implant, Cochlear	Unknown	Class 3	N/A	2005-08-10
MHE	Implant, Auditory Brainstem	Unknown	Class 3	N/A	2005-08-10
MCM	Implant, Cochlear	Unknown	Class 3	N/A	2005-08-10
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2012-05-29
MCM	Implant, Cochlear	Unknown	Class 3	N/A	2005-08-10
MCM	Implant, Cochlear	Unknown	Class 3	N/A	2022-02-17

Official Correspondent

No official correspondent registered.

US Agent Details

Laura Blair Business: Cochlear Americas Email: lblair@cochlear.com Phone: (800) 5235798

Related Public Records

Same Entity

COCHLEAR AMERICAS

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013177549	Cochlear Malaysia Sdn Bhd	Kuala Lumpur Kuala Lumpur, MY
9616024	COCHLEAR BONE ANCHORED SOLUTIONS AB	Molnlycke Vastra Gotaland, SE
3009092818	Cochlear Ltd	Macquarie University New South Wales, AU
9613646	Cochlear Limited - Brisbane	Newstead Queensland, AU
3014579188	Cochlear Americas Warehouse	Centennial, CO, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27

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
3039411139	EPIMINDER LIMITED	Melbourne Victoria, AU
3039640505	Epiminder America Inc	Irving, TX, US
3009092818	Cochlear Ltd	Macquarie University New South Wales, AU
3009762645	Advanced Bionics LLC	Valencia, CA, US
9611813	CHRISTIAN DIENER GMBH	TUTTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002806740. Last updated year: 2026. Please use registration number 3002806740 when referencing this establishment in official correspondence.