BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Custom Sound Pro

    Reg #: 3013177549 · FEI: 3013177549 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    11
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    Cochlear Malaysia Sdn Bhd
    Registration Number
    3013177549
    FEI Number
    3013177549
    Status
    Active
    Expiry Year
    2025
    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

    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
    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

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