FT.MDR.26: oral medical device based on simethicone registered in Kuwait under MD 13/22
We are pleased to announce that the medical device (MD) FT.MDR.26 has successfully completed the medical device registration in Kuwait, having been officially registered with the Kuwait Ministry of Health in compliance with the requirements of the Medical Device Regulation MD 13/22, which governs the placement on the market and distribution of medical devices in the country.
This approval confirms our commitment to quality, safety, and regulatory compliance, further strengthening our international presence in the field of products dedicated to gastrointestinal well-being and reinforcing our expertise in medical device registration in Kuwait and GCC markets.
The development and validation pathway of FT.MDR.26 is part of a broader portfolio of certified medical device products and solutions intended for international markets.
A certified medical device for the treatment of gastrointestinal disorders
FT.MDR.26 is a Class IIb medical device developed for the treatment of functional gastrointestinal disorders such as flatulence, gas colic, dyspepsia, and aerophagia—conditions commonly associated with the accumulation of gas in the digestive tract.
In Kuwait, the registration and market authorization process for medical devices is managed by the Ministry of Health according to specific national requirements, as reported in institutional market intelligence documents on the Kuwaiti medical sector (Kuwait Medical Devices – U.S. Department of Commerce).
The formulation combines simethicone in olive oil with vitamin E and coenzyme Q10, providing an effective anti-foaming, soothing, and protective action suitable for both adults and children.
Multicenter clinical studies conducted in pediatric populations have shown an 80% reduction in pain and bloating symptoms after 14 days of treatment, as assessed using the GIQLI (Gastrointestinal Quality of Life Index).
Technical characteristics and regulatory advantages
FT.MDR.26 is available in liquid oral formulations ranging from 10 ml to 100 ml, with precise dosing (20 drops = 40 mg of simethicone), and is free from preservatives, sugars, alcohol, and artificial flavorings.
The registration in Kuwait further consolidates our international presence. For additional completed international medical device registrations, please refer to the news and regulatory updates section.
Strategic expansion in the Gulf countries
Compliance with MD 13/22 represents a strategic milestone for expansion into the Gulf Cooperation Council (GCC) markets, where demand for medical devices aimed at treating flatulence and gas colic is steadily increasing.
FT.MDR.26 fully meets safety and quality requirements, offering regional distributors a pre-approved medical device ready for distribution.
We are certified manufacturers of medical devices, dietary supplements, and cosmetics, offering FT.MDR.26 ready to market or available in private label format, with full regulatory and technical support.
