BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Cochlear Malaysia Sdn Bhd

    Reg #: 3013177549 · FEI: 3013177549 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    37
    Establishment Types
    3
    Classifications
    7

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    Registration Details

    Registration Name
    Cochlear Malaysia Sdn Bhd
    Registration Number
    3013177549
    FEI Number
    3013177549
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Unit UG-1, Upper Ground Floor, Vertical Podium, The Vertical, Avenue 3, Bangsar South, No 8 Jalan Kerinchi
    City
    Kuala Lumpur Kuala Lumpur
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K002913
    PMA Number
    P970051

    Owner / Operator

    Firm Name
    COCHLEAR AMERICAS
    Operator Number
    9076254
    Address
    10350 Park Meadows Drive
    City
    Lone Tree
    State
    CO
    Postal Code
    80124
    Country
    US

    US Agent

    Business Name
    Cochlear Americas
    Contact Name
    Laura Blair
    Address
    10350 Park Meadows Drive
    City
    Lone Tree
    State
    CO
    ZIP
    80124
    Country
    US
    Email
    [email protected]
    Phone
    800 5235798

    Products

    Device Name Product Code
    Hearing Aid, Bone Conduction LXB
    Implant, Auditory Brainstem MHE
    Implant, Cochlear MCM
    Active Implantable Bone Conduction Hearing System PFO
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Hearing Aid, Bone Conduction, Implanted MAH
    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification PGQ

    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 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) Nucleus Auditory Brainstem Implant System Baha 5 SuperPower Sound Processor Cochlear OsiaTM System Baha 5 Baha 5 Power

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device