BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    KOSSAN LATEX INDUSTRIES (M) SDN BHD

    Reg #: 3005632797 · FEI: 3005632797 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    KOSSAN LATEX INDUSTRIES (M) SDN BHD
    Registration Number
    3005632797
    FEI Number
    3005632797
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LOT 6129,JALAN HAJI ABDUL MANAN, Batu 5 1/4, JALAN MERU
    City
    KLANG Selangor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K151750

    Owner / Operator

    Firm Name
    KOSSAN LATEX INDUSTRIES (M) SDN. BHD.
    Operator Number
    8040735
    Address
    LOT 16632, 5 1/4 MILES,, JALAN MERU
    City
    KLANG
    State
    Selangor
    Postal Code
    41050
    Country
    MY
    Correspondent
    LIM - KWAN HWA

    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 Glove, Specialty LZC
    Polymer Patient Examination Glove LZA

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)