BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Cochlear Ltd

    Reg #: 3009092818 · FEI: 3009092818 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    21
    Establishment Types
    6
    Classifications
    7

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    Registration Details

    Registration Name
    Cochlear Ltd
    Registration Number
    3009092818
    FEI Number
    3009092818
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1 University Ave
    City
    Macquarie University New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K191921
    PMA Number
    P890027

    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
    Implant, Cochlear MCM
    Implant, Auditory Brainstem MHE
    Active Implantable Bone Conduction Hearing System PFO
    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification PGQ
    Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring SEM
    Instrument, Ent Manual Surgical LRC
    Hearing Aid, Bone Conduction LXB

    Proprietary Names

    N22 COCHLEAR IMPLANT SYS FOR PED Nucleus Auditory Brainstem Implant System 7M Magnet for CP1000 5(I) Coils Osia 2 System Nucleus Hybrid L24 Implant System Cochlear OsiaTM System ENT Surgical N22 COCHLEAR IMPLANT SYS FOR ADULTS Cochlear™ Osia® System 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 5 SuperPower Sound Processor

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device