Ningbo Tianyi Medical Appliance Co., Ltd. (301097.SZ) has announced that it recently received the European Union Medical Device Regulation (MDR) certification under Regulation (EU) 2017/745, covering its Dialysis Concentrates, Powder product. This certification confirms that the company has established a quality management system aligned with the regulation, and the product meets current EU medical device compliance standards, granting it market access to the EU and other regions recognizing MDR certification.
The achievement is expected to facilitate the promotion and sales of the company's relevant products in the EU and other target markets, positively impacting its global competitiveness and future business development.