FT.CE.18 ear spray for ear canal hygiene, protection and prevention
The registration of the FT.CE.18 medical device with the Executive Department of Medical Devices Evaluation of the Medical Devices Sector of the Kingdom of Saudi Arabia marks a significant milestone in the international expansion of medical devices designed for ear hygiene and protection.
This approval confirms full compliance with the highest international standards of quality, safety, and efficacy, positioning FT.CE.18 among the most reliable solutions for preventing external ear canal conditions and maintaining ear health.
The clinical positioning of FT.CE.18 falls within the segment of ear hygiene, protection, and prevention devices, suitable for both adults and children exposed to risk factors such as swimming, humidity, or sudden temperature changes. It effectively meets the needs of cleanliness, pH balance, and infection prevention, three essential pillars for maintaining the integrity of the outer ear.
Formulated with a balanced hydroglyceric base, FT.CE.18 combines 3% boric acid, lactic acid, and sodium docusate—a synergistic trio that performs:
- Wax emulsification and removal, through the amphipathic action of sodium docusate.
- pH balancing of the auditory canal, maintaining a protective acidic environment.
- Reduction of bacterial and fungal proliferation due to the acidifying effect of boric acid.
- Soothing and hydration of the skin thanks to glycerin, propylene glycol, and chamomile.
Regular use helps prevent earwax plugs and reduces the risk of external otitis, especially in predisposed individuals and children frequently exposed to water environments such as pools or the sea.
FT.CE.18 is available in two complementary formulations:
- Ear Spray (50 ml) – ideal for daily hygiene and adults.
- Ear Drops (10 ml) – designed for pediatric use or sensitive ear canals, offering precise dosing and comfort.
The approval in Saudi Arabia strengthens the competitiveness of this medical device in a fast-growing Middle Eastern market, where the demand for ear care products continues to rise due to environmental and climatic conditions that favor irritation and wax accumulation.
FT.CE.18 is now available as a ready-to-market solution and in private label version, offering distributors and healthcare partners a fully certified ear hygiene device supported by complete technical documentation and regulatory assistance.
The fact that the FT.CE.18 medical device is already registered in Saudi Arabia allows to:
- Accelerate market entry
- Avoid long and complex documentation processes
- Collaborate with a partner that has successfully completed all regulatory stages
Being pre-approved in a target market represents a key strategic advantage, especially in the medical device industry, where registration timelines can significantly impact business growth and market planning.
Our goal is to make international expansion fast, safe, and fully compliant, leveraging extensive regulatory experience gained across multiple countries.
Certified manufacturer of medical devices, dietary supplements, and dermocosmetics, offers FT.CE.18 ready to market or available in private label version with full regulatory and technical support.
