On June 20, 2024, Leo Medical received a confirmation letter issued by the notified body, explicitly stating that LEOMED has submitted a formal application for MDR conformity assessment in accordance with the EU's extended transitional provisions bill for MDR.  Both parties have signed the MDR certification contract. Since then, the MDD CE certificate has been successfully extended, allowing the original MDD certificate to remain valid until December 31, 2028.

The successful extension of the MDD CE certificate marks a promising start for CE certification under MDR for Leo Medical. Currently, LEOMED is in the process of obtaining MDR certification for twelve products. MDR puts more stringent requirements on us, presenting both opportunities and challenges. Leo Medical will adhere to the principle of facing challenges head-on, seizing opportunities, and striving to achieve EU MDR CE certification at the earliest opportunity.
As a medical technology company born for innovation, Leo Medical adheres to the philosophy of focusing on people, relying on people, and serving people.  We employ concentric and horizontal strategic development approaches to provide comprehensive solutions for digestive endoscopy, respiratory intervention, and peripheral vascular treatment. Recognized as a national high-tech enterprise in 2018, Leo Medical boasts an outstanding team with international vision and extensive experience in the medical device industry.
In the future, Leo Medical will continue to be committed to import substitution, intensive cultivation in the field of professional segmentation, strengthen market penetration and share, in-depth layout of the international market, contribute to the strength of Leo people for domestic high-quality medical devices to the sea, guided by the real clinical needs, and continue to explore and open the innovation road of sustainable development!