CONTEC MEDICAL SYSTEMS CO. (SZ:300869) 中国基金报·2025-10-10 16:20Core Viewpoint - 康泰医学 received a warning letter from the FDA, which may impact its operations in the U.S. market in the future [2][4]. Group 1: FDA Warning and Compliance - The warning letter was issued based on an FDA inspection conducted from June 9 to June 12, 2025, which found that 康泰医学's medical device products did not comply with U.S. federal regulations 21 CFR Part 820 [4]. - 康泰医学 plans to respond to the FDA within the specified timeframe, detailing corrective actions and timelines to address the issues raised [4]. Group 2: Financial Impact - In 2024, 康泰医学 generated sales revenue of 114 million yuan from the U.S., accounting for 23.84% of its total revenue [4]. - In the first half of 2025, sales revenue from the U.S. was 41.89 million yuan, representing 19.26% of the company's total revenue [4]. - The company has a high export ratio, with 73.08% of its sales coming from international markets in 2024 [5][6]. Group 3: Shareholder Changes - As of September 16, 2025, the second-largest shareholder, 王桂丽, reduced her holdings to 40.18 million shares, representing 10% of the total share capital, down from 14.7% since 2021 [6]. Group 4: Market Performance - On October 10, 康泰医学's stock closed at 16.4 yuan per share, with a market capitalization of 6.59 billion yuan [7].