医用生物胶
Search documents
二类医疗器械再现违规注射 韩妃整形被撤销5A评级
Zhong Guo Jing Ying Bao· 2025-08-29 00:40
Core Viewpoint - The article highlights serious violations by Guangdong Hanfei Plastic Surgery Hospital regarding the promotion and use of a medical product labeled as "medical device number," leading to the revocation of its "AAAAA Medical Beauty Hospital" rating by the China Association of Plastic Surgery [1][2]. Company Summary - Guangdong Hanfei Plastic Surgery Hospital was established in September 2017 with a registered capital of 73.5 million yuan, controlled by Huang Zhaobiao and represented by Chen Jianhong [3]. - The hospital is part of a large cosmetic surgery chain that integrates clinical and research services [3]. - Since 2022, the hospital has been involved in multiple medical service contract disputes [3]. Product and Regulatory Summary - The product in question, "Silk 516 Energy Essence," is registered under the number "Xiang Medical Device Approval 20222141869" and is classified as a second-class medical device, which is only approved for external use and not for invasive injections [1][2]. - The product is manufactured by Xiangtan Huaxi Biotechnology Co., a wholly-owned subsidiary of Huaxi Biological (688363.SH) [1][2]. - The China Association of Plastic Surgery stated that the hospital's actions violated national medical device usage regulations and contradicted the integrity and quality standards required for the "AAAAA Medical Beauty Hospital" title [2]. Industry Context - The medical beauty market has seen a surge in demand for skin care products, but it is also plagued by issues such as counterfeit products and improper usage of medical devices [5][6]. - A report by Sullivan indicated that only 35% of medical beauty injectables in circulation are genuine, highlighting the prevalence of fake and substandard products in the market [5]. - Regulatory bodies, including the Guangzhou Health Commission, have initiated investigations into the hospital's practices and the use of the disputed product [6].