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Data / Medical devices / Thailand / SSL Manufacturing (thailand) Ltd.

SSL Manufacturing (thailand) Ltd.: FDA-registered device maker in BANGSAMAK,BANGPAKONG Chachoengsao, Thailand, 22 510(k) clearances

SSL Manufacturing (thailand) Ltd. is registered with the FDA (registration 3003071219) in BANGSAMAK,BANGPAKONG Chachoengsao, Thailand. It lists 5 device types. The FDA files 22 510(k) clearances under its listings, the newest dated February 28, 2025. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

FDA registration number
3003071219
Address
Wellgrow Industrial Estate 100 Moo 5, Bangna-Trad KM 36, BANGSAMAK,BANGPAKONG Chachoengsao, Thailand, 24180
Owner or operator
Reckitt Benckiser LLC (9004884)
Roles
Manufacturer, Specification developer
First device listed
May 23, 2007
Registered through
2026
Brand names listed
Durex 2 in 1 Massage Play Aloe Vera, Durex 2 in 1 Massage Play Guarana, Durex 2 in 1 Massage Play Ylang Ylang, Durex Adventure Pack, Durex Air Close Fit, Durex Air Regular Fit, Durex Cheeky Play Silicone Long Lasting Personal Lubricant, Durex Cheeky Play Silicone Long Lasting Pleasure Personal Lubricant and more

Devices it lists

DeviceProduct codeClassRoleSource
CondomHIS2Manufacturer, Specification developeraccessdata.fda.gov
Condom, SyntheticMOL2Manufacturer, Specification developeraccessdata.fda.gov
Device, External Penile RigidityLKY2Specification developeraccessdata.fda.gov
Lubricant, PatientKMJ1Specification developeraccessdata.fda.gov
Lubricant, PersonalNUC2Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 28, 2025K241617Durex Polyisoprene CondomMOLSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
November 7, 2022K220489Durex Patronus CloseFit, Durex Patronus RegularHISSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
October 12, 2022K222068Durex Penck III RegularHISSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
May 11, 2022K211152Durex Condom with BenzocaineHISSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
March 1, 2022K213400Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play StrawberryNUCSubstantially EquivalentRb Health (Us)accessdata.fda.gov
July 9, 2021K211088Grosz Play FeelNUCSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
July 30, 2020K201186KY Grosz JellyNUCSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
April 20, 2020K193032KY Grosz LiquidNUCSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
April 14, 2020K192982KY Grosz UltraGelNUCSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
May 17, 2019K183505KY Banksy MoistureNUCSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
April 16, 2019K183302KY Banksy AloeNUCSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
January 12, 2018K173504K-Y SiliconeNUCSubstantially EquivalentReckitt Benckiser, LLCaccessdata.fda.gov
January 11, 2016K151884K-Y Marilyn Pleasure GelNUCSubstantially EquivalentReckitt Benckiser, LLCaccessdata.fda.gov
November 8, 2013K122061K-Y BRAND LIQUIBEADSNUCSubstantially EquivalentJohnson & Johnson Healthcare Productsaccessdata.fda.gov
June 19, 2008K072169DUREX SYNTHETIC POLYISOPRENE MALE CONDOMMOLSubstantially EquivalentSsl Americas, Inc.accessdata.fda.gov
May 7, 2008K072236DUREX PLAY TINGLING AQUEOUS BASED LUBRICANTNUCSubstantially EquivalentSsl Americasaccessdata.fda.gov
March 10, 2008K063385DUREX PLAY MASSAGE GEL LUBRICANTNUCSubstantially EquivalentSsl Americas, Inc.accessdata.fda.gov
March 6, 2008K072421K-Y BRAND YOURS+MINENUCSubstantially EquivalentMcneil-Ppc, Inc.accessdata.fda.gov
March 23, 2007K070545K-Y BRAND WARMING LIQUIDNUCSubstantially EquivalentPersonal Products Co.accessdata.fda.gov
February 23, 2005K042563DUREX PLAY WARMER LUBRICANTKMJSubstantially EquivalentSsl Americas, Inc.accessdata.fda.gov
April 27, 2004K040185DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOMHISSubstantially EquivalentSsl Americasaccessdata.fda.gov
April 5, 2004K040164K-Y BRAND WARMING JELLY PERSONAL LUBRICANTNUCSubstantially EquivalentPersonal Products Company, Div. of Mcneil-Ppc, Inc.accessdata.fda.gov

Compare with other makers

Updated February 28, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.