FDA Registration
Active
🇹🇭 Thailand
SURETEX, LTD.
Reg #: 8040641
·
FEI: 3002808272
·
Expires 2026
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 protected]
- Phone
- 848 2293224
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Condom | HIS | Class 2 | Obstetrics/Gynecology | No | 2008-03-27 |
| Lubricant, Personal | NUC | Class 2 | Obstetrics/Gynecology | No | 2017-12-14 |
| Condom, Synthetic | MOL | Class 2 | Obstetrics/Gynecology | No | 2023-11-06 |
| Condom With Nonoxynol-9 | LTZ | Class 2 | Obstetrics/Gynecology | No | 2008-03-27 |
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