BEUDAMED
    FDA Registration Active 🇹🇭 Thailand

    LS ASST COLORS CONDOM STPS 2S 1000 HOTLINE

    Reg #: 8040641 · FEI: 3002808272 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SURETEX, LTD.
    Registration Number
    8040641
    FEI Number
    3002808272
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    31/1 Moo 4, Suratthani-Thakuapha Road, Tambon Khao Hua Kwai
    City
    Amphur Phunphin Surat Thani
    Country
    TH

    Regulatory Submissions

    510(k) Number
    K992081

    Owner / Operator

    Firm Name
    SURETEX, LTD.
    Operator Number
    9010022
    Address
    31/1 Moo4, Suratthani-Thakuapha Road, Tambon Khao Hua Kwai
    City
    Phunphin
    State
    Surat Thani
    Postal Code
    84130
    Country
    TH

    US Agent

    Business Name
    SXWELL USA LLC
    Contact Name
    ALEXANDRA KIRKLAND
    Address
    66 Hudson Blvd E, 24th Floor
    City
    New York
    State
    NY
    ZIP
    10001
    Country
    US
    Email
    [email protected]
    Phone
    848 2293224

    Products

    Device Name Product Code
    Condom HIS

    Proprietary Names

    LS ASST COLORS CONDOM STPS 2S 1000 HOTLINE Rider Midnight Black Condom BULK TESTED CONDOM BLACK 52 STRAIGHT SHAFT LIFESTYLES TUXEDO HYGEIA COLORS CONDOM BLACK LIFESTYLES ASSORTED COLORS CONDOM HOTLINE BLACK

    Establishment Types

    Manufacture Medical Device