BEUDAMED
    FDA Registration Active 🇹🇭 Thailand

    SURETEX, LTD.

    Reg #: 8040641 · FEI: 3002808272 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    144
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    SURETEX, LTD.
    Registration Number
    8040641
    FEI Number
    3002808272
    Status
    Active
    Expiry Year
    2026
    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
    K030176

    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
    Correspondent
    SUTTHIDA - CHAIYA

    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
    Lubricant, Personal NUC
    Condom, Synthetic MOL
    Condom With Nonoxynol-9 LTZ

    Proprietary Names

    Marathon Benzocaine Condoms Adam & Eve - Marathon condoms hims Climax Delay Latex Condoms (clockstopper) Rider Everlast LIFESTYLES NATURAL PERSONAL LUBRICANT Lifestyles Smooth 2-in-1 Massage and Lubricant/LIFESTYLES SMOOTH 2-IN-1 SKYN NATURALLY ENDLESS LUBRICANT SKYN SUPREME FEEL SKYN SUPREME FEEL EXTRA LUBRICATED LIFESTYLES CLOSER CONNECTION Rider Midnight Black Condom BULK TESTED CONDOM BLACK 52 STRAIGHT SHAFT LIFESTYLES TUXEDO LIFESTYLES ASSORTED COLORS CONDOM HOTLINE BLACK HYGEIA COLORS CONDOM BLACK LS ASST COLORS CONDOM STPS 2S 1000 HOTLINE SKYN WARMING CONDOM SKYN EXCITATION LIFESTYLES LARGE LIFESTYLES ULTRA SENSITIVE PLATINUM LARGE LIFESTYLES ULTRA SENSITIVE TITAN LIFESTYLES NYC KYNG MEGA RIDER LIFESTYLES KING GOLD/LIFESTYLES KYNG GOLD LIFESTYLES NYC LARGE SKYN KING XXL Polyisoprene Extra Large Condom SKYN XXL LIFESTYLES SENSATION MAX Lifestyles Warm Lovin Personal Lubricant SKYN SKYN COCKTAIL CLUB SKYN CHERRY SUNRISE SKYN PINA COLADA SKYN PASSION DAIQUIRI SKYN ELITE LARGE SKYN ORIGINAL SKYN ELITE LIFESTYLES NATURAL LATEX FREE SKYN EXTRA STUDDED SKYN ELITE EXTRA LUBE LIFESTYLES NON-LATEX PI SKYN SNUG FIT LIFESTYLES LARGE NON-LATEX SKYN KING ELITE LARGE EXTRA GLIDE SKYN LARGE SKYN KING SKYN SELECTION SKYN KING ULTRA THIN SKYN EXTRA LUBRICATED SKYN KING LARGE SKYN Snug Fit SKYN KING ELITE LARGE LS ZERO ORIGINAL LIFESTYLES ULTRA SENSITIVE PLATINUM LIFESTYLES ULTRA SENSITIVE PLATINUM EXTRA LUBE Lifestyles Intimate Moments Adam & Eve - Marathon condom BULK TESTED 49MM ID Premium Lubricated Condom - Extra Large Lifestyles Pleasure Ribbed Rough Rider Studded Flatpack WET RIDER Adam & Eve - Ribbed BULK TESTED RED 53 STRAIGHT SHAFT LS ULTRA LUBRICADO LIFESTYLES HIS & HERS LIFESTYLES STUDDED BULK (TESTED)-RIBBED CONTEMPO WET N' WILD BULK TESTED GREEN 53 STRAIGHT SHAFT CUSTOM PHILLY FLARED BULK TESTED YELLOW 53 STRAIGHT SHAFT LifeStyles Ultra Lube Plus ROUGH RIDER BULK (TESTED)-PINK COLOUR Adam & Eve - Ultra Thin Philly X Large LIFESTYLES LUBRICATED LIFESTYLES TOUGH Pepper Moon Custom "Good Times" LIFESTYLES ULTRA LUBRICATED LIFESTYLES ULTRA THIN LIFESTYLES EXTRA STRENGTH LIFESTYLES ULTRA SENSITIVE Pepper Moon Custom "Turn Me On" LIFESTYLES ASSORTED COLOURS LIFESTYLES NATURAL FEELING LIFESTYLES SNUGGER FIT CONTEMPO ROUGH RIDER BULK (TESTED)-DOTTED LIFESTYLES ULTRA SENSITIVE BRAVO Contempo BAREBACK LIFESTYLES RIBBED PLEASURE Adam & Eve - Hard Rider Philly Ribbed LIFESTYLES RIBBED BARE RIDER Pepper Moon Custom "Play Time" LIFESTYLES ULTRA SENSITIVO MUTUAL SENSATION STEAMWORKS ROUGH RIDER STUDDED CONDOM FLATPACK-BLUE ULTRA SHAPE COLORS Bikini Condom LIFESTYLES LUBRICATED ORIGINAL Philly X Large Condoms LIFESTYLES ULTRA RIBBED EVENING MAGIC CONDOM- LIGHT RED SAVAGE BLISS ULTRA SHAPE CLEAR BULK TESTED CONDOM BLUE 53 STRAIGHT SHAFT SAY IT WITH A CONDOM TURBO CONDOMS MOMENTOS BULK TESTED CONDOM BLACK 53 STRAIGHT SHAFT Bulk Tested CONDOM Flare Thin 53 MM STEAMWORKS LUBRICATED HYGEIA ULTRA CONDOM ID Premium Lubricate Condom - Extra Thin HYGEIA COLORS CONDOM BULK TESTED CONDOM NATURAL 52 STRAIGHT SHAFT EVENING MAGIC CONDOM- LIGHT YELLOW EVENING MAGIC CONDOM- LIGHT BLUE EVENING MAGIC CONDOM- LIGHT GREEN Lifestyles Luxe Premium Lubricant SKYN MAXIMUM PERFORMANCE PERSONAL LUBRICANT LifeStyles Liquid Personal Lubricant (Silicone) 4.5g Sachets SKYN ALL NIGHT LONG PERSONAL LUBRICANT Skyn Natural Feeling Personal Lubricant LIFESTYLES LIQUID PERSONAL LUBRICANT ALOE & VITAMIN E LIFESTYLES LIQUID PERSONAL LUBRICANT ALOE 1000 SKYN AQUA FEEL HOT RIDER LS SPL LS LUBRICATED W SPL LS ULTRA LUB W SPL Ultra Shape Clear CONDOM with NP9 # 420 SWEET RIDER LIFESTYLES ASSORTED FLAVORS LIFESTYLES ULTRA STUDDED LIFESTYLES NON LUBRICATED LATEX CONDOM LIFESTYLES ULTRA SENSITIVE NON-LUBRICATED STEAMWORKS NON LUBRICATED CONDOM

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility