BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    ASAP, Global Gloves

    Reg #: 3014593437 · FEI: 3014593437 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ASAP INTERNATIONAL SDN. BHD.
    Registration Number
    3014593437
    FEI Number
    3014593437
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO. 1, JALAN SITAR 33/6, SEKSYEN 33
    City
    SHAH ALAM Selangor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K001619

    Owner / Operator

    Firm Name
    ASAP INTERNATIONAL SDN. BHD.
    Operator Number
    10074712
    Address
    NO. 1, JALAN SITAR 33/6, SEKSYEN 33
    City
    SHAH ALAM
    State
    Selangor
    Postal Code
    40400
    Country
    MY

    US Agent

    Business Name
    FDAImports.com, LLC
    Contact Name
    FDAIMPORTS.COM LLC
    Address
    2631 Housley Road, #1211, Annapolis, Maryland, 21401, UNITED STATES
    City
    Annapolis
    State
    MD
    ZIP
    21401
    Country
    US
    Email
    [email protected]
    Phone
    410 2202800

    Products

    Device Name Product Code
    Polymer Patient Examination Glove LZA

    Proprietary Names

    ASAP, Global Gloves

    Establishment Types

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