BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    PERUSAHAAN GETAH ASAS SDN BHD

    Reg #: 3011198350 · FEI: 3011198350 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    PERUSAHAAN GETAH ASAS SDN BHD
    Registration Number
    3011198350
    FEI Number
    3011198350
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lot PT 54925, NO 5, JALAN KORPORAT 7C/KU9, TAMAN PERINDUSTRIAN MERU, MUKIM KAPAR
    City
    KLANG Selangor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K232461

    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
    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
    Medical Glove, Specialty LZC
    Fentanyl And Other Opioid Protection Glove QDO

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)