When it comes to patient well-being, safety and performance is non-negotiable. We at Tytex understand that our devices play a crucial role in supporting patients' medical needs and aiding in their recovery and treatment. That’s why all our medical devices comply and adhere to the highest standards of safety and performance as outlined by Medical Device Regulation (EU) 2017/745.

Our commitment goes beyond compliance - we continuously learn from healthcare professionals and patients to refine and enhance our devices. Their invaluable feedback allows us to innovate and ensure our devices meet real-world clinical needs.

By complying with the Medical Device Regulation (EU) 2017/745, we are entitled to place the CE mark on all our medical devices, demonstrating that they meet the highest standards of safety and performance. From development to end of lifecycle, our devices are designed and manufactured within a rigorous, comprehensive quality management system to ensure the health, safety, and well-being of those who use them.