BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    iSR'obot Kit

    Reg #: 3027381586 · FEI: 3027381586 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GLOBAL TECH PLASTIC INDUSTRY SDN BHD
    Registration Number
    3027381586
    FEI Number
    3027381586
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO.4,5,6, JALAN TIRAM 5, TAMAN PERINDUSTRIAN TIRAM
    City
    ULU TIRAM Johor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K232320

    Owner / Operator

    Firm Name
    GLOBAL TECH PLASTIC INDUSTRY SDN BHD
    Operator Number
    10091205
    Address
    NO.4,5,6, JALAN TIRAM 5, TAMAN PERINDUSTRIAN TIRAM
    City
    ULU TIRAM
    State
    Johor
    Postal Code
    81800
    Country
    MY
    Correspondent
    KOH SIOH CHIAN

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Biopsy Needle Guide Kit OIJ

    Proprietary Names

    iSR'obot Kit

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)