Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013177549

FEI Number

3013177549

Entity Name

Cochlear Malaysia Sdn Bhd

City/State/Country

Kuala Lumpur Kuala Lumpur, MY

Establishment Address

Unit UG-1, Upper Ground Floor, Vertical Podium, The Vertical, Avenue 3, Bangsar South, No 8 Jalan Kerinchi, Kuala Lumpur Kuala Lumpur 59200, MY

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

K231604

PMA Number

N/A

All Registered Proprietary Names

Headband for Baha NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Cochlear Surgical Instrument Upgrade Kit Nucleus SmartNav Cochlear Nucleus Kanso 3 Nexa Sound Processor and accessories Cochlear Nucleus 8 Nexa Sound Processor and Accessories Cochlear Nucleus Nexa cochlear implants Cochlear Nucleus Kanso 3 Sound Processor and accessories Nucleus Smart App Cochlear Objective Measures Cochlear surgical processors and accessories Custom Sound Pro Baha 6 Max Sound Processor Baha Smart App Baha Fitting Software 6 Osia 2 System Cochlear Baha 7 System Baha Smart App Baha 7 Sound Processor and Accessories Cochlear SoundBand Baha Fitting Software 7 Baha Attract BAHA IMPLANT SYSTEM Instrument Case Cochlear Baha® Fitting Software 6 Cochlear Baha® Baha Smart App Cochlear Baha® System Baha BA400 Abutment Nucleus Hybrid L24 Implant System Cochlear Osia® System Ba400 14mm Abutment Baha BIA300 Implants with Abutments Instrument Case (Phase 2)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2008-10-23
MHE	Implant, Auditory Brainstem	Unknown	Class 3	N/A	2005-08-10
MCM	Implant, Cochlear	Unknown	Class 3	N/A	2005-08-10
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2021-02-23
PFO	Active Implantable Bone Conduction Hearing System	Ear, Nose, Throat	Class 2	874.3340	2019-11-19
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2025-06-02
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2013-11-18
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2005-08-11
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2023-09-13
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2022-01-17
MAH	Hearing Aid, Bone Conduction, Implanted	Ear, Nose, Throat	Class 2	874.3302	2012-11-19
PGQ	Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification	Unknown	Class 3	N/A	2014-04-16
PFO	Active Implantable Bone Conduction Hearing System	Ear, Nose, Throat	Class 2	874.3340	2023-08-29
MAH	Hearing Aid, Bone Conduction, Implanted	Ear, Nose, Throat	Class 2	874.3302	2015-07-23
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2010-10-06
MAH	Hearing Aid, Bone Conduction, Implanted	Ear, Nose, Throat	Class 2	874.3302	2023-09-13
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2023-09-13
PFO	Active Implantable Bone Conduction Hearing System	Ear, Nose, Throat	Class 2	874.3340	2023-09-13

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
3002806740	COCHLEAR LTD.	LANE COVE New South Wales, AU
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
K243425	Talladium España, SL	Guided DAS Surgical Kit	2025-07-22
K213209	K1 Medical, LLC	EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device	2021-12-28
K012105	Symmetry Medical, Inc.	POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM	2002-08-02
K243317	Infinitum Eta, Ltd.	NUVENTUS NV.C Surgical Cassette and Tray	2025-02-11
K112536	Covidien	SONICISION STERILIZATION TRAY	2012-04-19

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
3014990990	SONITUS MEDICAL (SHANGHAI) CO., LTD.	shanghai, CN
3034209804	YUH JAAN INDUSTRIAL CO., LTD.	Taichung City, TW
3005900820	COCHLEAR AMERICAS	Lone Tree, CO, US
9613646	Cochlear Limited - Brisbane	Newstead Queensland, AU
3007367732	Oticon Medical AB	Askim Vastra Gotaland, SE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013177549. Last updated year: 2026. Please use registration number 3013177549 when referencing this establishment in official correspondence.