BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    WEAR SAFE (MALAYSIA) SDN. BHD.-FACILITY II

    Reg #: 3010195579 · FEI: 3010195579 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    WEAR SAFE (MALAYSIA) SDN. BHD.-FACILITY II
    Registration Number
    3010195579
    FEI Number
    3010195579
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LOT 63616, PT 54924, NO 3, Jalan Korporat 7C/KU9, Taman Perindustrian Meru, Mukim Kapar,
    City
    Klang Selangor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K051378

    Owner / Operator

    Firm Name
    WEAR SAFE (MALAYSIA) SDN. BHD.-FACILITY II
    Operator Number
    10043522
    Address
    LOT 63616, PT 54924, NO 3, Jalan, Korporat 7C/KU9,Taman Perindustrian Meru
    City
    Mukim Kapar, Klang
    State
    Selangor
    Postal Code
    42200
    Country
    MY
    Correspondent
    LIM SIEW BING

    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
    Polymer Patient Examination Glove LZA

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)