BEUDAMED
    FDA Registration Active 🇨🇳 China

    SoundBite

    Reg #: 3014990990 · FEI: 3014990990 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SONITUS MEDICAL (SHANGHAI) CO., LTD.
    Registration Number
    3014990990
    FEI Number
    3014990990
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Floor 5, Bldg. 11 & Floor 4-5, Bldg. 7, 500 Furonghua Rd, Pudong, Shanghai
    City
    shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K100649

    Owner / Operator

    Firm Name
    Sonitus Medical (Shanghai) Co., Ltd.
    Operator Number
    10060074
    Address
    Bldg.11-F5/7-F4&5, 500 Furonghua Rd., Pudong District
    City
    shanghai
    State
    CN-SH
    Postal Code
    201318
    Country
    CN
    Correspondent
    yang ji

    US Agent

    Business Name
    ALEMBIC, LLC
    Contact Name
    AARON BEREZ
    Address
    627 NATIONAL AVE MOUNTAIN VIEW, CALIFORNIA, 94043, UNITED STATES
    City
    Mountain View
    State
    CA
    ZIP
    94043
    Country
    US
    Email
    [email protected]
    Phone
    650 3885088

    Products

    Device Name Product Code
    Hearing Aid, Bone Conduction LXB

    Proprietary Names

    SoundBite

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device