BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    AAMEDIX GLOVE SDN BHD

    Reg #: 3017207705 · FEI: 3017207705 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    AAMEDIX GLOVE SDN BHD
    Registration Number
    3017207705
    FEI Number
    3017207705
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit 19D, Level 19, No.16, Persiaran Setia Dagang, Bandar Setia Alam, 40170 Shah Alam, Selangor Darul Ehsan
    City
    Shah Alam Selangor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K220121

    Owner / Operator

    Firm Name
    AAMedix Glove Sdn Bhd
    Operator Number
    10084933
    Address
    Unit 19D, Level 19, No. 16, Persiaran Setia Dagang, Bandar Setia Alam,, 40170 Shah Alam, Selangor Darul Ehsan, Malaysia
    City
    Shah Alam
    State
    Selangor
    Postal Code
    40170
    Country
    MY
    Correspondent
    ENG SOON KER

    US Agent

    Business Name
    Mexpo International Inc.
    Contact Name
    Tim Thai
    Address
    2828 Faber Street
    City
    Union City
    State
    CA
    ZIP
    94587
    Country
    US
    Email
    [email protected]
    Phone
    510 4896800

    Products

    Device Name Product Code
    Polymer Patient Examination Glove LZA

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198