Recently, the group's MEDA ophthalmic A/B ultrasonic diagnostic instrument and urology bladder ultrasonic volume measuring instrument series products successfully obtained EU MDR certification, which marks that MEDA has obtained the "Latest Pass" in the EU market. Several products have undergone strict compliance assessments and entered the ranks of MDR certification, which is a full affirmation of MEDA's sound quality management system.

MEDA always regards building a quality management system as its top priority to ensure continuous optimization and improvement of product quality and functions. This has helped the Company obtain certifications from many countries such as Europe, America, Japan, and South Korea, demonstrating MEDA attaches great importance to the safety, effectiveness and quality assurance of its products.

The European Union Medical Device Regulation (MDR) was issued on April 5, 2017 and officially replaces the Medical Device Directive 93/42/EEC (MDD) and the Active Implantable Medical Device Directive 90/385/EEC (AIMDD) from May 26, 2020. Compared with the former MDD Directive, MDR puts forward stricter requirements in terms of supervision intensity, certification difficulty, product quality and safety assessment, corporate compliance and technical gold content.

Obtaining the MDR certification this time demonstrates the Company's long-term efforts to adhere to independent innovation and research and development and continuously improve the quality management system. It reflects the high recognition of the safety and effectiveness of MEDA's products in the international market, providing important opportunities for MEDA's exploration of European and even global markets. In the future, MEDA will continue to be committed to optimizing its quality management system, continuously improving the adaptability of all product lines to the requirements of regulations and standards in various countries and regions around the world, and providing safe, effective, and reliable medical device products for agents and patients under the scientific guidance and guarantee of the system, protecting MEDA's global development.