格隆汇1月7日丨迈克生物(300463.SZ)公布，近日收到国家药品监督管理局颁发的《医疗器械注册证》 （体外诊断试剂），产品名称：交叉配血质控品。交叉配血质控品系公司血型平台新增质控品，主要用 于手工法及全自动血型分析系统交叉配血试验的质量控制。新产品取得注册证进一步丰富了公司产品项 目菜单，有助于提升公司市场综合竞争力，对市场的拓展以及公司未来的经营将产生积极影响。 ...

Core Viewpoint - Anjie's subsidiary, Hangzhou Anji Medical Technology Co., Ltd., has received a medical device registration certificate from the Zhejiang Provincial Drug Administration, enhancing its product line in the endoscopy field and improving market competitiveness [1] Group 1: Product Registration - The medical device registration certificate is valid from December 23, 2025, to December 22, 2030 [1] - The registered products include electronic endoscope image processors, upper gastrointestinal electronic endoscopes, and lower gastrointestinal electronic endoscopes [1] Group 2: Product Functionality - These products are designed to process signals from electronic endoscopes, provide illumination, and work in conjunction with image processors to display images for observation, diagnosis, and treatment of the upper and lower gastrointestinal tracts [1] Group 3: Market Impact - The acquisition of the registration certificate enriches the company's product line in the endoscopy sector, which is expected to enhance its overall competitiveness in the market [1]

东方生物12月19日公告，公司全资子公司美国衡健、哈尔滨东方基因、万子健生物近日取得多项医疗器 械注册证，包括6项细胞因子检测试剂盒、睾酮测定试剂盒、泌乳素测定试剂盒等国内医疗器械注册 证，以及新冠/甲乙流抗原联合检测试剂(自测)(胶体金法)等国际医疗器械注册证。这些注册证的取得将 进一步完善公司在呼吸道专项检测或联检产品、时间分辨荧光免疫层析法检测产品、流式荧光发光法检 测产品、荧光免疫分析仪等领域的产品布局，有利于相关技术平台产品的整体市场拓展。但实际销售业 绩取决于产品的实际竞争力和市场销售能力，目前尚无法预测对公司未来经营业绩的影响。 ...

Group 1 - The first extraordinary general meeting of shareholders for Shenzhen Pumen Technology Co., Ltd. was held on December 16, 2025, at the company's headquarters in Shenzhen [2] - All resolutions proposed during the meeting were approved, with no rejected proposals [2] - The meeting was convened by the board of directors and chaired by Chairman Liu Xiancheng, following legal and procedural requirements [2][3] Group 2 - The meeting included the attendance of all 9 current directors and 3 supervisors, along with the board secretary and senior management [3] - Several governance-related proposals were passed, including the cancellation of the supervisory board and amendments to the company's articles of association and related rules [4][5] - A proposal for the company to apply for a comprehensive credit limit from banks for the year 2026 was also approved [5] Group 3 - The company recently received two medical device registration certificates for in vitro diagnostic reagents from the Guangdong Provincial Drug Administration [9] - The registered products are composite quality control products that ensure the safety and effectiveness of the company's electrochemical luminescence detection system [9] - As of the announcement date, the company and its subsidiaries have obtained a total of 105 registration certificates for electrochemical luminescence detection reagents, enhancing its product competitiveness in the immunodiagnostic field [9]

亚辉龙公告，全资子公司湖南亚辉龙生物科技有限公司近日收到湖南省药品监督管理局签发的医疗器械 注册证。注册证产品为抗磷脂酰丝氨酸/凝血酶原IgM抗体测定试剂盒（化学发光法）和抗磷脂酰丝氨 酸/凝血酶原IgG抗体测定试剂盒（化学发光法），注册编号分别为湘械注准20252400986和湘械注准 20252400987，有效期至2030年12月11日。上述注册证的取得，有利于进一步丰富公司的全自动化学发 光产品线，完善亚辉龙的自身免疫性疾病领域检测套餐。 ...

Core Viewpoint - The company has received medical device registration certificates for two products, the surgical shadowless lamp and the thoracic and abdominal endoscope, which are expected to enhance its product offerings and competitive edge in the medical device market [1][6]. Group 1: Surgical Shadowless Lamp - Product Name: Surgical Shadowless Lamp [1] - Registration Number: Lu Xie Zhu Zheng 20252010721 [1] - Features: Ultra-thin butterfly design, high color rendering medical LED light source, multiple modes for clinical needs [2] - Applicable Scope: Designed for surgical lighting in medical institutions [1] - Approval Date: November 27, 2025 [1] - Validity Period: Until November 26, 2030 [1] - Market Context: 101 companies in the same industry have obtained similar product registration certificates [1]. Group 2: Thoracic and Abdominal Endoscope - Product Name: Thoracic and Abdominal Endoscope [8] - Registration Number: Lu Xie Zhu Zheng 20252060702 [8] - Features: Dual-mode confocal design, ultra-clear imaging, and durable sapphire lens [5] - Applicable Scope: Used for examination and observation in thoracic and abdominal surgeries [4] - Approval Date: November 19, 2025 [4] - Validity Period: Until November 18, 2030 [4] - Market Context: 13 companies in the same industry have obtained similar product registration certificates [4]. Group 3: Impact on Company Performance - The surgical shadowless lamp meets diverse clinical lighting needs, enriching the company's surgical product line [6] - The thoracic and abdominal endoscope complements the company's medical fluorescence endoscope imaging system and minimally invasive surgical instruments, enhancing its product variety and core competitiveness [6].

Core Viewpoint - Antu Biology (603658.SH) has received medical device registration certificates from the National Medical Products Administration and the Henan Provincial Medical Products Administration, enhancing its product offerings and competitiveness in the market [1] Group 1: Company Developments - The company and its wholly-owned subsidiary, Zhengzhou Sikun Biological Engineering Co., Ltd., along with its secondary subsidiary, Zhengzhou Biaoyuan Biotechnology Co., Ltd., have recently obtained medical device registration certificates [1] - The acquisition of these certificates enriches the company's product menu and meets market demand, serving as an effective supplement to existing testing products [1] Group 2: Market Impact - The new medical device registration is expected to gradually improve the overall competitiveness of the company's products [1] - The short-term impact on the company's operating performance is considered to be minimal [1]

Core Viewpoint - The company Wanfu Bio has received a medical device registration certificate from the National Medical Products Administration for its combined test kit for respiratory syncytial virus (RSV), adenovirus (ADV), and Mycoplasma pneumoniae (MP) antigens, which is expected to positively impact its product offerings and sales growth [1] Group 1 - The product is designed for in vitro qualitative detection of RSV, ADV, and MP antigens in nasopharyngeal swab samples [1] - The approval of the product registration certificate will increase the variety of products available for sale by the company [1] - The company plans to actively promote the sales of the related products, although it is currently unable to predict the impact on future revenue [1]

Core Viewpoint - The announcement indicates that the company has received a medical device registration certificate from the National Medical Products Administration for its blood type identification and irregular antibody screening quality control products, which is expected to enhance its market competitiveness and future operations [1] Group 1: Product Development - The new product registration enriches the company's product portfolio, potentially aiding in market expansion [1] - The actual sales performance of the registered products will depend on future market promotion efforts [1] Group 2: Market Impact - The registration certificate is anticipated to have a positive impact on the company's overall market competitiveness [1] - The future revenue impact of the new product remains unpredictable at this stage [1]

Core Viewpoint - The company, Longshen Rongfa, has received a medical device registration certificate for its blood dialysis concentrate from the National Medical Products Administration, indicating a significant regulatory milestone for its product line [1] Group 1: Product Details - The blood dialysis concentrate consists of two parts: A concentrate and B concentrate [1] - A concentrate includes sodium chloride (NaCl), potassium chloride (KCl), calcium chloride (CaCl2.2H2O), magnesium chloride (MgCl2.6H2O), acetic acid (CH3COOH), and dialysis water [1] - B concentrate is composed of sodium bicarbonate (NaHCO3) and dialysis water [1] Group 2: Application Scope - The product is intended for use in the treatment of acute renal failure and chronic renal failure through blood dialysis [1]