Huadong Medicine Subsidiary Secures EU MDR CE Certification for Medical Device

Stock News08-09 16:40

Huadong Medicine Co.,Ltd. (000963.SZ) announced that its wholly-owned UK subsidiary, Sinclair Pharma Limited ("Sinclair"), has obtained EU MDR CE certification for KIO015, a novel injectable carboxymethyl chitosan solution with a unique patented composition.

The certification, granted as the world's first and currently only innovative non-animal-derived chitosan aesthetic injection product, grants KIO015 market access eligibility in the European Union. Marketed under the brand name Kytogen ® Defend, the product's EU MDR CE certification confirms compliance with EU market上市 requirements, allowing sales in the EU and related overseas markets.

This development is not expected to significantly impact the company's current financial position or operating results, though it may positively contribute to future performance. The product has not yet obtained a domestic medical device registration certificate in China and has not generated any sales revenue to date.

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