BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    KOSSAN INTERNATIONAL SDN BHD

    Reg #: 3009538921 · FEI: 3009538921 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    KOSSAN INTERNATIONAL SDN BHD
    Registration Number
    3009538921
    FEI Number
    3009538921
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    KOSSAN Tower, No. 6D, Persiaran Setia Dagang, Setia Alam, Seksyen U13,
    City
    Shah Alam Selangor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K232461

    Owner / Operator

    Firm Name
    Kossan International Sdn Bhd
    Operator Number
    10039751
    Address
    KOSSAN Tower No. 6D, Persiaran Setia Dagang, Setia Alam, Seksyen U13
    City
    Shah Alam
    State
    Selangor
    Postal Code
    40170
    Country
    MY
    Correspondent
    Lim Siau Tian

    US Agent

    Business Name
    Parexel International
    Contact Name
    Sowmya Sony Janampally
    Address
    2520 Meridian Parkway, Research Triangle Park, Suite 200
    City
    Durham
    State
    NC
    ZIP
    27713
    Country
    US
    Email
    [email protected]
    Phone
    978 5456290

    Products

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

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility