BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Cochlear Limited - Brisbane

    Reg #: 9613646 · FEI: 3003045432 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    18
    Establishment Types
    3
    Classifications
    6

    Registration Details

    Registration Name
    Cochlear Limited - Brisbane
    Registration Number
    9613646
    FEI Number
    3003045432
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    12 Helen Street
    City
    Newstead Queensland
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K153245
    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
    Active Implantable Bone Conduction Hearing System PFO
    Implant, Auditory Brainstem MHE
    Implant, Cochlear MCM
    Instrument, Ent Manual Surgical LRC
    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification PGQ

    Proprietary Names

    Baha 5 SuperPower Sound Processor Cochlear OsiaTM 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 N22 COCHLEAR IMPLANT SYS FOR ADULTS ENT Surgical Nucleus Auditory Brainstem Implant System N22 COCHLEAR IMPLANT SYS FOR PED Nucleus Hybrid L24 Implant System

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device