Core Viewpoint - The company Jiuan Medical (002432.SZ) announced that its U.S. subsidiary, iHealth Labs Inc., has received pre-market notifications from the U.S. Food and Drug Administration (FDA) for several diagnostic test kits, allowing them to be sold in the U.S. market [1] Group 1: Product Approvals - The following products received FDA 510(K) pre-market notifications: 1. A four-in-one home test kit for detecting Influenza A, Influenza B, COVID-19, and RSV (Respiratory Syncytial Virus) [1] 2. A four-in-one professional test kit for the same viruses [1] - Additionally, a three-in-one home test kit for Influenza A, Influenza B, and COVID-19, as well as a three-in-one professional test kit, also received FDA 510(K) pre-market notifications [1]

其中包括iHealth美国的甲型流感、乙型流感、COVID-19及RSV呼吸道合胞病毒四联检测家用试剂盒； 甲型流感、乙型流感、COVID-19及RSV呼吸道合胞病毒四联检测专业用试剂盒收到美国FDA 510(K)上 市前通知（"四联检试剂盒"）。以及甲型流感、乙型流感及COVID-19病毒三联检测家用试剂盒；甲型 流感、乙型流感及COVID-19病毒三联检测专业用试剂盒收到美国FDA 510(K)上市前通知（"三联检试 剂盒"）。上述产品取得上市前通知后，均可在美国市场正常销售。 北京商报讯（记者 丁宁）12月14日晚间，九安医疗（002432）发布公告称，公司于北京时间12月13日 获悉，公司美国子公司iHealth Labs Inc.（以下简称"iHealth美国"）的产品收到了美国食品药品监督管理 局（FDA）的上市前通知。 ...

Core Viewpoint - The company Jiuan Medical (002432.SZ) announced that its U.S. subsidiary, iHealth Labs Inc., received pre-market notifications from the FDA for two types of diagnostic test kits for respiratory viruses, indicating a significant step in product development and potential market entry [1]. Group 1: Product Announcements - iHealth Labs Inc. received FDA 510(K) pre-market notifications for a four-in-one home test kit that detects Influenza A, Influenza B, COVID-19, and RSV [1]. - The company also received FDA 510(K) pre-market notifications for a three-in-one home test kit that detects Influenza A, Influenza B, and COVID-19 [1].

天津九安医疗电子股份有限公司 关于美国子公司四联检、三联检产品 获得美国FDA上市前通知的公告 本公司及董事会全体成员保证信息披露的内容真实、准确和 完整，没有虚假记载、误导性陈述或重大遗漏。 天津九安医疗电子股份有限公司（以下简称"公司"）于北京时间2025年12 月13日获悉，公司美国子公司iHealth Labs Inc.（以下简称"iHealth美国"）的以 下产品收到了美国食品药品监督管理局（FDA）的上市前通知： 1、甲型流感、乙型流感、COVID-19及RSV呼吸道合胞病毒四联检测家用 试剂盒；甲型流感、乙型流感、COVID-19及RSV呼吸道合胞病毒四联检测专业 用试剂盒收到美国FDA 510(K)上市前通知（以下简称"四联检试剂盒"）。 2、甲型流感、乙型流感及COVID-19病毒三联检测家用试剂盒；甲型流感、 乙型流感及COVID-19病毒三联检测专业用试剂盒收到美国FDA 510(K)上市前 通知（以下简称"三联检试剂盒"）。 证券代码：002432 证券简称：九安医疗 公告编号：2025-098 | | | | | | 该产品获准用于非处方（OTC）家庭 | | --- | --- | ...

Core Viewpoint - The ban on the production of mercury thermometers and sphygmomanometers starting next year has sparked significant discussion on social media, with various medical device companies responding to the news and indicating minimal impact on their operations [1] Company Responses - Yuyue Medical stated that it will strictly comply with national laws and regulations, and the ban will not significantly affect its business as it has been focusing on developing electronic blood pressure monitors and thermometers [1] - Cofo Medical mentioned that its primary products are infrared thermometers, indicating no reliance on mercury thermometers [1] - Jiann Medical confirmed that it has never produced mercury thermometers, focusing instead on electronic models [1] - Yingqu Technology noted that its thermometer business is relatively small and primarily consists of electronic types [1] - Aojiahua stated that it does not produce mercury thermometers, highlighting its offering of infrared thermometers [1]

Core Viewpoint - The Chinese government will ban the production of mercury thermometers and sphygmomanometers starting January 1, 2026, marking the end of mercury-based medical devices in the market [1] Company Impact - Yuyue Medical stated that the volume of mercury thermometer and sphygmomanometer products in its business is very small, as the company primarily focuses on electronic products [1] - Jiuan Medical indicated that it is not a traditional thermometer manufacturer, and the impact on the company can be considered negligible [1] Market Response - There is a reported shortage of mercury thermometers on e-commerce platforms, with available products mainly being glass and electronic thermometers [1]

Core Points - The Chinese government will ban the production of mercury thermometers and blood pressure monitors starting January 1, 2026, in compliance with the Minamata Convention on Mercury [1][3] - The ban is driven by the toxic nature of mercury and its environmental hazards, with a standard mercury thermometer containing about 1 to 2 grams of mercury, which can significantly exceed safe concentration levels if broken [1][3] - Following the announcement, there has been a surge in demand for mercury thermometers on e-commerce platforms, leading to stock shortages due to their low price compared to electronic alternatives [1][8] Policy Background - The ban is part of China's commitment to the Minamata Convention, which took effect in China on August 16, 2017, and was further detailed by the National Medical Products Administration in October 2020 [3] - The environmental and health risks associated with mercury, including irreversible damage to the nervous system and kidneys, particularly in vulnerable populations like children and pregnant women, are key considerations for the ban [3] Market Reaction - E-commerce platforms like JD.com and Taobao have reported limited stock and shortages of mercury thermometers following the announcement of the ban [3] - The price of mercury thermometers is generally under 10 yuan, while electronic thermometers range from tens to hundreds of yuan, creating a significant price difference that drives consumer behavior [8] Company Responses - Companies such as Yuyue Medical (002223), Jiuan Medical (002432), and Kefu Medical (301087) have indicated that the impact of the ban on their businesses will be limited, as the share of mercury products in their portfolios is small [9][10] - Yuyue Medical, once a leader in the mercury blood pressure monitor market with an 85% market share, has transitioned to electronic products and reported a revenue of 7.972 billion yuan in 2023 [9] - Jiuan Medical stated that it is not a traditional thermometer manufacturer and has minimal exposure to mercury products, suggesting that the exit of mercury products may create opportunities in the electronic thermometer market [10] Industry Outlook - The global blood pressure monitor market is projected to grow from 2.15 billion USD in 2025 to 3.97 billion USD by 2032, with a compound annual growth rate of 9.2% [10] - The market for electronic thermometers and infrared measuring devices is expected to expand as consumer preferences shift away from mercury products [10][12] - Major players in the electronic blood pressure monitor market include Omron and Yuyue, with domestic brands like Jiuan and Kefu gaining market share through e-commerce strategies [12]

Core Viewpoint - The Chinese government will ban the production of mercury thermometers and sphygmomanometers starting January 1, 2026, marking the end of mercury-based medical devices in the market [1]. Company Impact - Companies such as Yuyue Medical (002223.SZ), Jiuan Medical (002432.SZ), and Kefu Medical (301078.SZ) are currently selling mercury thermometers and sphygmomanometers, but their impact from the ban is expected to be minimal as they primarily focus on electronic products [1]. - Yuyue Medical stated that the volume of mercury-based products in their business is very small, with a major focus on electronic devices [1]. - Jiuan Medical indicated that they are not traditional manufacturers of thermometers and that their main revenue source comes from reagent kits, particularly in the U.S. market [1]. Market Trends - There has been a noticeable increase in demand for mercury thermometers on e-commerce platforms, leading to stock shortages, while electronic and glass thermometers remain available [2]. - In physical pharmacies, staff reported that mercury thermometers are selling out quickly, with many customers still preferring them despite the availability of electronic alternatives [4]. - The price of electronic thermometers and infrared thermometers is significantly higher, often exceeding 100 yuan, compared to the low price of mercury thermometers, which can be as low as 6.1 yuan [4]. Industry Response - Some medical enterprises have already stopped using mercury thermometers in anticipation of the ban and are transitioning to compliant products [5]. - Pharmacies have not yet received official notifications regarding the prohibition of selling mercury thermometers, indicating a potential lag in industry compliance [5].

Core Viewpoint - The Chinese government will ban the production of mercury-containing thermometers and blood pressure monitors starting January 1, 2026, marking the end of mercury thermometers in the market [1]. Company Impact - Companies such as Yuyue Medical (002223.SZ) and Jiuan Medical (002432.SZ) have indicated that the impact of this ban on their business will be minimal, as they primarily focus on electronic products and have a very small volume of mercury thermometer and blood pressure monitor sales [1]. - Jiuan Medical stated that it is not a traditional thermometer manufacturer and that its main revenue source comes from reagent kits, particularly in the U.S. market [1]. Market Observations - There has been a noticeable increase in demand for mercury thermometers on e-commerce platforms, leading to stock shortages, while electronic and glass thermometers are more readily available [2]. - In physical pharmacies, staff reported that mercury thermometers are selling out quickly, with many customers still preferring them despite the availability of electronic alternatives [4][6]. Transition to Alternatives - Pharmacies are increasingly stocking electronic and infrared thermometers, which are priced significantly higher than mercury thermometers, indicating a shift in consumer preference [4][6]. - Medical companies are preparing to transition away from mercury products in compliance with government regulations, although some have not yet received formal notifications regarding the sales ban [6].

Core Viewpoint - The Chinese government will ban the production of mercury-containing thermometers and blood pressure monitors starting January 1, 2026, marking the end of mercury thermometers in the market [1]. Company Impact - Companies such as Yuyue Medical (002223.SZ) and Jiuan Medical (002432.SZ) have indicated that the impact of this ban on their business will be minimal, as they primarily focus on electronic products and have a very small volume of mercury thermometer and blood pressure monitor sales [1][5]. - Jiuan Medical stated that their main revenue source comes from reagent kits, particularly in the U.S. market, and they are not traditional manufacturers of thermometers [1]. Market Observations - There has been a noticeable increase in demand for mercury thermometers on e-commerce platforms, leading to stock shortages, while electronic and glass thermometers are more readily available [2]. - In physical pharmacies, staff reported that they have sold out of mercury thermometers due to increased demand, especially during the flu season, but they still offer electronic and infrared thermometers at significantly higher prices [4]. Industry Transition - Some medical companies have already begun transitioning away from mercury thermometers in anticipation of the ban, although they have not received formal notifications regarding the prohibition of sales [5]. - The market is expected to shift towards electronic and infrared thermometers, which are perceived as more convenient, especially for families with young children [4].