半岛大超炮
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媛颂集团与半岛医疗达成战略合作 首发“械三”证大超炮
Zheng Quan Shi Bao Wang· 2025-11-10 13:33
Core Insights - The strategic partnership between Yuansong Group and Peninsula Medical marks the launch of China's first approved Class III ultrasonic medical beauty device, enhancing compliance in the aesthetic medicine market [1][2] - The Chinese aesthetic medicine industry has reached a market size of hundreds of billions, with the non-invasive anti-aging sector experiencing double-digit growth, despite challenges such as equipment qualification and quantifiable results [1] Group 1: Strategic Partnership - The collaboration aims to integrate Peninsula Medical's 14 years of research in developing the first Class III ultrasonic medical beauty device with Yuansong's established compliance service system [1] - The "Half Island Super Cannon" received approval for Class III medical device registration at the end of October, becoming the first ultrasonic medical beauty device in China to obtain this certification [1] Group 2: Compliance and Service - Yuansong's competitive advantage lies in the dual assurance of compliant equipment and transparent services, filling a gap in the compliant ultrasonic anti-aging service sector [2] - The company has established nearly 30 direct-operated clinics in 20 major cities, serving over one million consumers, and has formed strategic partnerships with several listed companies to promote high-standard products [2]
率先获批超声医美器械领域“械三证”,半岛医疗破局!千亿级市场迎来洗牌时刻
Mei Ri Jing Ji Xin Wen· 2025-11-04 07:22
Core Viewpoint - The Chinese medical aesthetics device industry is entering a new development stage characterized by high standards, strong regulation, and genuine innovation, as evidenced by the approval of the first "Class III Medical Device" registration certificate for ultrasound aesthetic equipment by the National Medical Products Administration (NMPA) [1][2]. Industry Overview - The approval of the first "Class III Medical Device" certificate marks a significant shift in the medical aesthetics device market, moving towards a high-standard and highly regulated environment [2][4]. - The certification process for Class III medical devices is rigorous, comparable to that of implantable products like pacemakers and artificial joints, requiring comprehensive evidence across the entire product lifecycle [2][3]. Company Insights - The company, Peninsula Medical, has spent over a decade focusing on clinical needs and technology development, positioning itself as a leader in innovation and compliance within the domestic energy source medical aesthetics device sector [1][3]. - Peninsula Medical's commitment to compliance and high standards has allowed it to be one of the few companies to successfully navigate the Class III certification process, having initiated its clinical and registration applications as early as 2021 [3][8]. Market Dynamics - The introduction of the "Class III Medical Device" certificate is expected to reshape market competition and accelerate industry consolidation, with companies that obtain this certification gaining significant advantages in the market [5][12]. - The high technical barriers and market exclusivity associated with the "Class III Medical Device" certification are anticipated to drive revenue growth for certified companies, as downstream medical aesthetic institutions will prioritize products with this certification [5][12]. Technological Advancements - Peninsula Medical has made several original technological breakthroughs, including the "shadow launch technology" and "intelligent ultrasound imaging system," which enhance treatment precision and comfort [7][8]. - The company invests over 25% of its revenue into research and development, employing a large team of nearly 400 R&D personnel, which is among the highest ratios in the industry [7][8]. Global Expansion - Peninsula Medical is expanding its reach into global markets, having received FDA approval for its products and entering prestigious institutions in the United States, reflecting its transition from a domestic equipment manufacturer to a global trusted brand [11][12].
国家药监局发出首张超声医美设备“三类证”, 再次花落深圳企业
Sou Hu Cai Jing· 2025-11-03 12:17
Core Viewpoint - The "beauty economy" in Shenzhen is rapidly rising, driven by policies and innovation, with the medical beauty industry showcasing unique competitiveness [1][2]. Group 1: Industry Development - The National Medical Products Administration (NMPA) issued the first Class III certificate for ultrasound medical beauty equipment to Shenzhen Peninsula Medical Group's "Peninsula Super Ultrasound" device, marking a significant breakthrough in high-end medical beauty equipment [1][4]. - The medical beauty industry in China is expected to exceed 400 billion yuan by 2025, with the non-surgical light medical beauty market expanding rapidly due to its low risk and quick recovery characteristics [2][4]. - The term "ultrasound cannon" originated in Shenzhen, and since its launch in mid-2021, over 4 million treatments have been performed, averaging more than 3,000 treatments per day [3][4]. Group 2: Regulatory Environment - The release of the "Guiding Principles for the Classification of Ultrasound Devices for Beauty Use" by the NMPA indicates a shift towards stricter regulations for ultrasound medical beauty devices, requiring them to meet Class III medical device standards [4][5]. - The transition from Class II to Class III certification involves higher safety standards and stricter entry barriers, which can take several years to achieve [5][6]. Group 3: Technological Advancements - The "Peninsula Super Ultrasound" device is the first in the domestic medical beauty sector to incorporate an intelligent ultrasound imaging system, enhancing the precision of treatment [8][6]. - Clinical studies have shown that the device significantly improves skin laxity, with a satisfaction rate exceeding 90% among participants [6][8]. Group 4: Company Growth and Investment - Since its establishment in 2008, Peninsula Medical has become a national-level specialized "little giant" enterprise, ranking among the top six global energy source medical beauty equipment companies [9][11]. - The company invests 25% to 27% of its annual sales revenue into research and development, having obtained nearly 70 global certifications and applied for over 1,000 domestic and international patents [11].