BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    SURE Latex Ultrasonic Probe Cover

    Reg #: 9613994 · FEI: 3009084570 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    PLEASURE LATEX PRODUCTS SDN. BHD.
    Registration Number
    9613994
    FEI Number
    3009084570
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LOT 5322, 15TH MILES, JALAN PADANG GAJAH
    City
    JERAM Selangor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K022156

    Owner / Operator

    Firm Name
    PLEASURE LATEX PRODUCTS SDN. BHD.
    Operator Number
    9032729
    Address
    LOT 5322, 15TH MILES, JALAN PADANG GAJAH
    City
    JERAM, SELANGOR DARUL EHSAN
    State
    MY-NOTA
    Postal Code
    45800
    Country
    MY
    Correspondent
    LIM KOI - YONG

    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
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    SURE Latex Ultrasonic Probe Cover

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device