BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Custom Sound Pro

    Reg #: 3014579188 · FEI: 3014579188 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    11
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    Cochlear Americas Warehouse
    Registration Number
    3014579188
    FEI Number
    3014579188
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7101 S. Fulton St., Suite E
    City
    Centennial
    State
    CO
    ZIP
    80112
    Country
    US

    Regulatory Submissions

    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
    Correspondent
    Laura - Blair

    Products

    Device Name Product Code
    Implant, Auditory Brainstem MHE
    Implant, Cochlear MCM

    Proprietary Names

    Custom Sound Pro Cochlear Nucleus 8 Nexa Sound Processor and Accessories Cochlear Objective Measures NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Nucleus Smart App Cochlear Nucleus Kanso 3 Nexa Sound Processor and accessories Cochlear Nucleus Nexa cochlear implants Nucleus SmartNav Cochlear Surgical Instrument Upgrade Kit Cochlear Nucleus Kanso 3 Sound Processor and accessories Cochlear surgical processors and accessories

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198