Core Viewpoint - 康泰医学 received a warning letter from the FDA on October 2, 2025, which restricts the company's products from entering the U.S. market until compliance issues are resolved [1][2] Group 1: FDA Warning and Compliance Issues - The warning letter was based on an FDA inspection conducted from June 9 to June 12, 2025, which found that the company's medical device products did not meet the requirements of the U.S. federal regulations 21CFR Part 820 [1][2] - The specific product models affected by the warning were not disclosed, indicating that all medical devices exported to the U.S. may be impacted [2] Group 2: Financial Impact and Market Dependency - The U.S. market is a significant revenue source for 康泰医学, accounting for 23.84% of total revenue in the previous year and 19.26% in the first half of this year [1][3] - In 2024, the company achieved sales revenue of 114 million yuan from the U.S., and in the first half of 2025, the revenue was 41.89 million yuan [3] Group 3: Market Expansion and Challenges - 康泰医学 has been expanding its product matrix in the U.S., with 24 products receiving FDA certification as of the 2025 semi-annual report [3] - The company is facing increased challenges due to stricter international trade policies and regulatory changes, particularly in the U.S. market [4][5] - To mitigate risks, 康泰医学 is focusing on expanding into markets in Africa, Europe, Southeast Asia, and South America, while optimizing product distribution [5] Group 4: Historical Context and Performance - 康泰医学 went public in August 2020, with a significant initial stock price increase of 1061%, largely due to the COVID-19 pandemic and the surge in demand for medical devices like pulse oximeters [2] - The company has experienced declining performance, with net profit decreasing for four consecutive years from 2021 to 2024, including a loss of 77.9 million yuan last year [5]