We are glad to announce the big news that, in December Singclean Medical's absorbable hemostat product, its Surgiclean absorbable hemostatic particles get certificated by MDR (Medical Device Regulation). This milestone achievement further demonstrates the company's excellence in medical technology innovation and paves the way for expansion into international markets.
MDR is a new EU medical device regulation that was officially implemented in 2021. It imposes stricter requirements on the safety, performance, and clinical evaluation of medical devices. Gaining MDR certification not only means that Surgiclean products meet with the latest EU regulatory requirements, but also demonstrates Singclean Medical's leading position in quality management and technology research and development in the field of medical products.
During the MDR certification process, Surgiclean absorbable hemostatic particles underwent rigorous clinical validation, quality system review, and technical document evaluation. The review agency highly praised the product's safety, effectiveness, and innovation.
Surgiclean absorbable hemostatic particles based on innovative hemostatic materials, has the advantages of effective, safe and easy to use. Its can stop bleeding effectively within 3 minutes and suitable for various kinds of surgeries. It is indicated in surgical as an adjunctive hemostatic device to assist when control of capillary, venous, and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical. With microspheres structure, it can expand its surface area to absorb more water in the blood to achieve better stop bleeding effects. The plant-based materials can make it more biodegradable and safe!
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Getting the certification of MDR, means Surgiclean absorbable hemostatic particles underwent rigorous clinical validation, quality system review and technical documentation evaluation, and can enter EU markets.
It means Surgiclean's compatibility in international markets improve a lot, lay a solid foundation for the Singclean Medical to enter the EU and other international markets. In the future, Singclean medical will keep exploring the potential applications of hemostatic dressing and find more innovative solution for surgeries.