Huadong Medicine (000963.SZ) subsidiary medical devices have obtained EU MDR CE certification.
East China Medical (000963.SZ) announced that its wholly-owned subsidiary in the UK, Sinclair Pharma Limited (referred to as "Sinclair"), has recently received EU MDR CE certification for its new injectable carboxymethyl chitosan solution KIO015. This certification grants access to the EU market, making it the world's first and currently only innovative non-animal derived chitosan injection product for medical aesthetics.
Huadong Medicine (000963.SZ) announced that its wholly-owned subsidiary in the UK, Sinclair Pharma Limited (referred to as "Sinclair"), has recently obtained EU MDR CE certification for a new injectable carboxymethyl chitosan solution KIO015, which possesses a patented composition. This makes it the world's first and currently the only innovative non-animal-derived chitosan aesthetic injection product approved for market entry in the EU.
The KIO015 (brand name: Kytogen Defend) product's receipt of EU MDR CE certification indicates that it meets the relevant requirements for market entry in the EU and is qualified to be sold in the EU and related overseas markets. This matter will not have a significant impact on the company's current financial position and operating results, but it is expected to positively influence the company's future performance. The product has obtained EU MDR CE certification but has not yet received a domestic medical device registration certificate and has not yet generated actual sales revenue.
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