Huadong Medicine's v30 device clears registration hurdle
Huadong Medicine (SZSE:000963) announced that its wholly-owned subsidiary, Viora Ltd., received an acceptance notice from the National Medical Products Administration (NMPA) on March 5, 2025, for its application to register the V30 optical radiofrequency therapy device as a Class III medical device. The V30 is a multi-functional aesthetic platform developed by Sinclair, incorporating RF, IPL, and Nd:YAG laser energy sources. The device is already FDA and CE certified. A similar product, V20 (Renotion), was approved in China in September 2024. The company stated the V30 acceptance is a step toward registration in China, but the ultimate market launch depends on regulatory approval and market conditions.
This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com
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