– 510k clearanced in US FDA
– Classification: Personal lubricant
– Product: wettrust VM
– Medical Device Class 2

CE, Europe

– CE certification in Europe
– Classification: Vaginal moisturizer / Vaginal Applicator
– Product: wettrust / wettrust VA / Repair Massage Gel
– Medical Device class 2a / Medical Device class 1

JPAL, Japan

– Medical device manufacturer

KGMP, Korea

– GMP for Medical Devices

CGMP, Korea

– CGMP for Cosmetic

MDA, Malaysia

– MDA Wettrust VAGINAL MOISTURIZER
– Medical device registration certificate
– Product : wettrust VM
– Class : Class B

ISO 13485:2016

– ISO 13485
– Medical devices Quality management systems
– International Organization for Standardization
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