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医美“超声炮” 首拿“三类证”
Shen Zhen Shang Bao· 2025-11-04 06:42
Core Viewpoint - The issuance of the first Class III certificate for ultrasound medical beauty equipment in China marks a significant breakthrough for Shenzhen Peninsula Medical Group, indicating the entry of domestic ultrasound medical devices into a higher compliance era [1][2][4] Industry Summary - The Chinese medical beauty industry is projected to exceed 400 billion yuan by 2025, driven by the booming "beauty economy" and the rapid expansion of the non-surgical light medical beauty market due to its low risk and quick recovery characteristics [2] - The term "ultrasound cannon" originated in Shenzhen, with Peninsula Medical's product being the first ultrasound medical device to receive NMPA certification in China [2][3] Company Summary - Peninsula Medical's ultrasound cannon series holds approximately 80% market share in its niche, with over 100,000 units sold and coverage in more than 10,000 hospitals and medical institutions globally [3] - The "Peninsula Big Ultrasound Cannon" took nearly four years to obtain the Class III certificate, involving extensive clinical trials and regulatory compliance [3][4] - The recent regulatory changes require ultrasound beauty devices to adhere to the strictest safety standards, with Class III devices needing clinical validation before market entry, establishing a "gold standard" for the industry [3][4]