BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    AIMAX HEALTHCARE SDN. BHD. (Formerly known as Hong Seng Gloves Sdn. Bhd.)

    Reg #: 3021233711 · FEI: 3021233711 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    AIMAX HEALTHCARE SDN. BHD. (Formerly known as Hong Seng Gloves Sdn. Bhd.)
    Registration Number
    3021233711
    FEI Number
    3021233711
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    LOT 97, JALAN 10,, KAWASAN PERUSAHAAN BAKAR ARANG,
    City
    SUNGAI PETANI Kedah
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K212804

    Owner / Operator

    Firm Name
    AIMAX HEALTHCARE SDN. BHD.
    Operator Number
    10083806
    Address
    LOT 97, JALAN 10, KAWASAN PERUSAHAAN BAKAR ARANG
    City
    SUNGAI PETANI
    State
    Kedah
    Postal Code
    08000
    Country
    MY
    Correspondent
    MAGESH RAMANADAN

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Polymer Patient Examination Glove LZA
    Fentanyl And Other Opioid Protection Glove QDO
    Medical Glove, Specialty LZC
    Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs OPJ

    Proprietary Names

    Powder Free Nitrile Examination Glove - Blue, Non Sterile Powder Free Nitrile Examination Glove - Black, Non-Sterile Powder Free Nitrile Examination Glove - White, Non-Sterile Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl

    Establishment Types

    Manufacture Medical Device