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Theraclion Secures Key Chinese Certification, Advancing Toward Market Access in China
MALAKOFF, France, October 21, 2025--Regulatory News: THERACLION (ISIN: FR0010120402; Mnemo: ALTHE), an innovative company developing Sonovein®, a robotic platform for non-invasive High-Intensity Focused Ultrasound (HIFU) varicose vein treatment, announces today that its Sonovein® has successfully passed China’s GB 9706.1-2020 medical electrical equipment safety standard — the national equivalent of the internationally recognized IEC 60601-1 normative framework.
About this update from Theraclion Sa
[{"type":"text","content":"MALAKOFF, France, October 21, 2025--(BUSINESS WIRE)--Regulatory News:","length":69,"tagName":"p"},{"type":"text","content":"THERACLION (ISIN: FR0010120402; Mnemo: ALTHE), an innovative company developing Sonovein®, a robotic platform for non-invasive High-Intensity Focused Ultrasound (HIFU) varicose vein treatment, announces today that its Sonovein® has successfully passed China’s GB 9706.1-2020 medical electrical equipment safety standard — the national equivalent of the internationally recognized IEC 60601-1 normative framework.","length":412,"tagName":"p"},{"type":"text","content":"This certification confirms that Sonovein® meets the latest Chinese requirements for electrical safety and focused ultrasound emissions for medical devices, validating the robustness of its design and manufacturing processes. It demonstrates Sonovein®’s ability to meet the stringent technical and safety criteria established by the National Medical Products Administration (NMPA), the Chinese regulatory authority.","length":415,"tagName":"p"},{"type":"text","content":"From a regulatory standpoint, compliance with GB 9706.1-2020 is a pivotal milestone in the NMPA approval pathway, ensuring that Sonovein® fulfills one of the core prerequisites for market authorization in China.","length":211,"tagName":"p"},{"type":"text","content":"Next steps","length":10,"tagName":"p"},{"type":"text","content":"This achievement marks significant progress toward market authorization and commercialization in China, one of the world’s largest and most dynamic markets for advanced medical technologies. With this certification secured, Sonovein® remains firmly on track to deliver on its international expansion strategy and bring the benefits of its non-invasive ultrasound innovation to a broader patient population.","length":406,"tagName":"p"},{"type":"text","content":"About Theraclion","length":16,"tagName":"p"},{"type":"text","content":"Theraclion is a French MedTech company committed to developing a non-invasive alternative to surgery through the innovative use of focused ultrasound.","length":150,"tagName":"p"},{"type":"text","content":"High Intensity Focused Ultrasound (HIFU) does not require incisions or an operating room. HIFU treatment concentrates therapeutic ultrasounds on an internal focal point from outside the body.","length":191,"tagName":"p"},{"type":"text",...