BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    BIWAZE COUGH

    Reg #: 3017373426 · FEI: 3017373426 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ADVANCED BIO MACHINES PTE. LTD.
    Registration Number
    3017373426
    FEI Number
    3017373426
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    36 Robinson Road, #20-01 City House
    City
    SINGAPORE Central Singapore
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K191912

    Owner / Operator

    Firm Name
    Advanced Bio Machines Pte. Ltd.
    Operator Number
    10083610
    Address
    36 Robinson Road, #20-01 City House
    City
    SINGAPORE
    State
    Central Singapore
    Postal Code
    068877
    Country
    SG
    Correspondent
    Thevane Kumar

    US Agent

    Business Name
    ABMRC LLC
    Contact Name
    Leah Noaeill
    Address
    860 Blue Gentian Road Suite 200
    City
    Eagan
    State
    MN
    ZIP
    55121
    Country
    US
    Email
    [email protected]
    Phone
    612 4191071

    Products

    Device Name Product Code
    Device, Positive Pressure Breathing, Intermittent NHJ

    Proprietary Names

    BIWAZE COUGH

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device