BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    KAREX INDUSTRIES SDN BHD

    Reg #: 9680135 · FEI: 1000535235 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KAREX INDUSTRIES SDN BHD
    Registration Number
    9680135
    FEI Number
    1000535235
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PTD. 7906/7907, TAMAN PONTIAN JAYA, BT. 34, JALAN JOHOR
    City
    PONTIAN Johor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K991892

    Owner / Operator

    Firm Name
    KAREX INDUSTRIES SDN BHD
    Operator Number
    9007040
    Address
    PTD. 7906/7907, Taman Pontian Jaya, BT. 34, Jalan Johor
    City
    Pontian
    State
    Johor
    Postal Code
    82000
    Country
    MY
    Correspondent
    Leng Kian - Goh

    US Agent

    Business Name
    Global Protection Corp.
    Contact Name
    Davin Wedel
    Address
    12 Channel Street
    City
    Boston
    State
    MA
    ZIP
    02210
    Country
    US
    Email
    [email protected]
    Phone
    617 9462800

    Products

    Device Name Product Code
    Condom HIS

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)