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Tianyi Medical's Hemodialysis Dry Powder Receives EU MDR Certification
Tianyi Medical announced on September 23 that it has recently received the European Union Medical Device Regulation, or MDR, certification for its hemodialysis dry powder. The company stated that obtaining the EU MDR certificate demonstrates it has established a quality management system aligned with the regulation, that the product complies with current EU medical device regulatory requirements, and that it is qualified to enter the EU market as well as other countries and regions that recognize EU MDR certification. In the first half of 2026, Tianyi Medical achieved revenue of 338 million yuan and net profit attributable to the parent company of 16.12 million yuan.
301097.CS · Regulation · Positive Tianyi Medical received EU MDR certification for its hemodialysis dry powder, qualifying it to enter the EU and other MDR-recognizing markets.