Recommended browser guide

This website is only available in Internet Explorer version 9 or later.
Please upgrade to the latest browser for convenient site use.

About

Expertise

Expertise

International Certificates of both product approval
and quality management system that Wettrust achieved give trust to customers.

acc1

CE marking (Directive 93/42/EEC)

  • Medical Device Class 2a
  • Wettrust Vaginal Moisturizer
  • KR15/02438
  • 18.June.2015
  • SGS UK
acc2

Japan Medical Divice Class 2(JPAL)

  • Medical Divice Class2
  • inclear
  • 225AFBZX0002100
  • 9.November.2012
acc3

US FDA Human OTC Drug

  • Human OTC Drug
  • inclear, Gold
  • inclear (NDC 59543-2001 & 59543-3001)
    Gold (NDC 59543-1001 & 5001)
  • 29.July.2013
  • USA FDA
acc4

ISO9001:2008

  • The management system
  • Sales and Distribution of Feminine Cleanser and Lubricant
  • KR13/02110
  • 29.November.2013
  • SGS UK
acc5

ISO 13485:2003 / EN ISO 13485:2012

  • The management system
  • Sales and Distribution of Feminine Cleanser and Lubricant
  • KR13/02109
  • 29.November.2013
  • SGS UK
14001

ISO 9001:2015

  • The management system
  • Design, Decelopment and Manufacturing of Cosmetics
  • KR16/02629
  • 14.July.2005
  • SGS UK
22716

ISO 14001:2015

  • The management system
  • Design, Decelopment and Manufacturing of Cosmetics
  • KR13/02633
  • 14.July.2005
  • SGS UK
9001

ISO9001:2008

  • The management system
  • Design, Decelopment and Manufacturing of Cosmetics
  • KR14/02165
  • 17.April.2014
  • SGS Belgium

About International Certificates of Product Approval

  • 01. JPAL

    inclear, Class 2 Medical Device

    It is necessary to achieve an approval of Ministry of Health, Labour and Welfare(MHLW) to distribute medical devices in Japan. Getting the approval from MHLW is very difficult and complicated because it requires lots of time and costs. With this reason, medical devices from advanced companies only can get the approval. inclear—Wettrust’s feminine cleanser for the Japanese market—achieved the approval from MHLW successfully as class 2.

    • - Class 1 : General medical devices.
    • - Class 2 : Controlled medical devices/designated controlled medical devices.
    • - Class 3~4 : Specially controlled medical devices.
  • 02. FDA OTC Drug

    inclear, gold

    FDA OTC drugs are the drugs acknowledged safe and appropriate to use without supervision of a health care professional, such as a physician. In addition, people can buy OTC drugs without prescriptions. Wettrust products (inclear, gold) are acknowledged as FDA OTC Drug since 2013.

  • 03. CE Marking

    wettrust Vaginal Moisturizer: Non-medicated lubricant gel for relieving vaginal dryness, Medical device class 2a

    CE marking is an important procedure that guarantees product’s conformity to EU regulations. Manufacturers, importers and distributors of non-food products are obligatory to provide the CE marking if they want to trade on EU/EEA(European Economic Area). Wettrust product (wettrust Vaginal Moisturizer) achieved CE Marking in 2015.

About International Certificates of Quality Management System

  • 01. ISO 9001

    ISO 9001 sets out the criteria for a quality management system. This standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement.
    Wettrust acquired ISO 9001 in 2013 for giving trust to customers.

  • 02. ISO 13485

    ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
    Wettrust acquired ISO13485 in 2013 to meet higher international standard for medical devices.

THREE ADVANTAGES OF WT APPLICATOR

applicatior

Cap

Gasket

Plunger

  • Cleanness

    • Individually wrapped applicator
    • Single-use only applicator free from secondary infection.
  • Safety

    • Safe streamlined patented applicator(easy & smooth penetration).
    • Advanced technology preventing gel leaks when the cap is not removed entirely.
  • Convenience

    • Possible to use without water anytime, anywhere.
    • Compact size, light weight to carry every where.
TOP