证券代码：688389 证券简称：普门科技 公告编号：2025-084 深圳普门科技股份有限公司 ● 本次会议是否有被否决议案：无 一、会议召开和出席情况 （一）股东大会召开的时间：2025年12月16日 （二）股东大会召开的地点：广东省深圳市龙华区求知东路8号普门科技总部大厦22楼会议室 （三）出席会议的普通股股东、特别表决权股东、恢复表决权的优先股股东及其持有表决权数量的情 况： 决议公告 本公司董事会及全体董事保证公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容的 真实性、准确性和完整性依法承担法律责任。 重要内容提示： 2025年第一次临时股东大会 ■ （四）表决方式是否符合《公司法》及公司章程的规定，大会主持情况等。 本次股东大会由董事会召集，由董事长刘先成先生主持，会议以现场投票和网络投票相结合的方式进行 表决。本次会议的召集、召开和表决程序符合《中华人民共和国公司法》《中华人民共和国证券法》 《深圳普门科技股份有限公司章程》的规定。 （五）公司董事、监事和董事会秘书的出席情况 1、公司在任董事9人，出席9人； 2、公司在任监事3人，出席3人； 3、公司董事会秘书路曼女士出席了本次会 ...

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。 ...

证券代码：600587 证券简称：新华医疗 公告编号：临2025-063 山东新华医疗器械股份有限公司 关于公司产品获得二类医疗器械注册证的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性承担个别及连带责任。 山东新华医疗器械股份有限公司（以下简称"公司"或"新华医疗"）和控股子公司新华手术器械有限公司 于近日收到山东省药品监督管理局颁发的《中华人民共和国医疗器械注册证》，具体情况如下： 一、医疗器械注册证的具体情况 （一）手术无影灯 1、产品名称：手术无影灯 2、注册证编号：鲁械注准20252010721 3、注册人名称：山东新华医疗器械股份有限公司 4、注册人住所：山东省淄博市高新技术产业开发区新华医疗科技园 5、生产地址：淄博高新区齐祥路3588号 6、结构及组成：产品由灯头、悬臂组件和安装固定组件组成。其中安装固定组件包括基座和下延柱， 悬臂组件包括横譬和弹簧臂，灯头包括上弯管、下弯管、灯头主体、可拆卸手柄和臂控面板。 超薄蝶形外观，设计轻巧使用方便，满足手术室层流需求；高显色性医用LED光源，高质量还原日光色 彩；产品配备了R ...

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]

Core Viewpoint - Antu Biology (603658.SH) has received multiple medical device registration certificates from the Henan Provincial Drug Administration, enhancing its product offerings and competitiveness in the market [1] Group 1 - The acquisition of medical device registration certificates enriches the company's product menu [1] - The new certifications effectively supplement the company's existing testing products [1] - The short-term impact on the company's operating performance is expected to be minimal [1]

Core Viewpoint - The company, Aihuilong, has received medical device registration certificates for two products from the Guangdong Provincial Drug Administration, enhancing its product line in the field of liver and kidney disease diagnostics [1] Group 1: Product Registration - The two registered products are the anti-gp210 IgG antibody test kit and the anti-phospholipase A2 receptor IgG antibody assay kit, both utilizing chemiluminescence technology [1] - The registration certificates are valid until November 25, 2030, and both products are classified as Class II medical devices [1] Group 2: Diagnostic Applications - The products are intended for auxiliary diagnosis of primary biliary cholangitis and idiopathic membranous nephropathy [1] Group 3: Market Impact - The company has obtained a total of 176 domestic medical device registration certificates for chemiluminescence reagents [1] - The new certifications will help enrich the fully automated chemiluminescence product line, but the sales performance of these products is subject to market conditions, making the impact on financial performance difficult to predict [1]

Core Viewpoint - The company has received a medical device registration certificate for its fully automated fluorescent immunoassay analyzer, which is expected to enhance its competitiveness and market expansion capabilities, although the impact on performance remains uncertain due to various influencing factors [1] Group 1: Product Registration - The company received the medical device registration certificate from the Guangdong Provincial Drug Administration [1] - The registration number is 粤械注准20252221513, and it is valid until November 17, 2030 [1] - The analyzer is classified as a Class II medical device [1] Group 2: Product Capabilities - The analyzer can test human serum and plasma samples [1] - It has a maximum processing capacity of 72 samples per hour [1] Group 3: Market Implications - The certification represents a breakthrough for the company in the field of multi-detection [1] - The sales performance of the product will be influenced by various factors, making the impact on financial performance unpredictable [1]