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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
中经记者陈婷赵毅深圳报道 一款标注"医用械字号"的水光产品在院方人员的推介中被混淆适用范围,院方对其产品资质作出误导性 陈述,并诱导消费者接受违规注射服务。 近期,广东韩妃整形外科医院(以下简称"韩妃整形")因上述行为被中国整形美容协会撤销"AAAAA医 疗美容医院"评价等级(以下简称"5A评级"),并被指"在经营活动中存在严重失信与违规问题"。 中国整形美容协会发布的通知显示,8月4日,中央电视台《财经调查》栏目集中曝光部分医疗美容机构 存在严重违规行为。其中,韩妃整形在其大众点评平台上架一款标注"医用械字号"的"丝丽516动能 素"水光产品(售价228元)。经核查,该产品实际仅持有第二类医疗器械注册证,国家明确规定其适用 范围仅限于外用,严禁用于侵入性注射。 据央视报道,上述涉事产品注册证编号为"湘械注准20222141869",注册人名称为华熙生物科技(湘 潭)有限公司(以下简称"湘潭华熙"),其为华熙生物(688363.SH)全资子公司。该产品用于非慢性 创面及周围皮肤的护理,为创面愈合提供微环境。 近日,记者联系采访韩妃整形方面,一位吕姓负责人在电话中回应称,上述央视报道相关内容"不属 实",并匆匆 ...
绽媄娅入局“械字号”,一次来自再生医学的降维打击
FBeauty未来迹· 2025-05-23 14:43
Core Viewpoint - The article discusses the launch of the RGD Recombination Collagen Repair Stick by the skincare brand Zhanmeiya under Baiao Regeneration, highlighting its entry into the medical device market and the growing intersection of regenerative medicine and the medical beauty industry [2][4]. Market Trends - The medical beauty market in China is expected to grow at a compound annual growth rate (CAGR) of 10%-15% over the next five years, potentially reaching a market size of 3.8 trillion by 2027 [4]. - The demand for perioperative care products, such as medical dressings, is growing even faster than the medical beauty market itself [4][5]. Product Development - Zhanmeiya's RGD collagen repair stick is designed to meet the increasing demand for skin barrier repair among medical beauty consumers, particularly post-surgery and for sensitive skin [7][10]. - The product utilizes advanced technologies, including "ball collagen," "ball peptide," and "ball PDRN," to enhance its effectiveness in skin repair [10][30]. Scientific Innovation - The RGD collagen repair stick features RGD-modified recombinant collagen, which allows for precise adhesion and effective repair of the skin barrier, addressing issues such as redness and pigmentation [19][24]. - Clinical results show that the product can reduce skin redness by 16.03% within 15 minutes and improve skin glossiness by 14.85% [19][20]. Competitive Landscape - The entry of Zhanmeiya into the medical device market signifies a shift towards a more scientific approach in the beauty industry, with an emphasis on research and development [12][30]. - The article notes that many beauty brands are now competing in the medical device space, leading to a rational new phase of competition characterized by quality and efficacy [5][13]. Marketing Strategy - Zhanmeiya has engaged in innovative marketing strategies, including collaborations with influencers to enhance brand visibility and consumer engagement [35][36]. - The brand's recent marketing efforts have resulted in significant sales growth, positioning it as a leading player in the market [32][35].