BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    PERUSAHAAN GETAH ASAS SDN. BHD.

    Reg #: 3004553390 · FEI: 3004553390 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    PERUSAHAAN GETAH ASAS SDN. BHD.
    Registration Number
    3004553390
    FEI Number
    3004553390
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    LOT 1365, BATU 17, JALAN SUNGAI SEMBILANG
    City
    JERAM Selangor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K042805

    Owner / Operator

    Firm Name
    PERUSAHAAN GETAH ASAS SDN BHD
    Operator Number
    8040956
    Address
    LOT 1365, BATU 17, JALAN SUNGAI SEMBILANG, --
    City
    JERAM
    State
    Selangor
    Postal Code
    45800
    Country
    MY

    US Agent

    Business Name
    Parexel International
    Contact Name
    Avani Patel
    Address
    541 Church At North Hills St
    City
    Raleigh
    State
    NC
    ZIP
    27609
    Country
    US
    Email
    [email protected]
    Phone
    978 4358575

    Products

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

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device