Core Viewpoint - The company, Maike Biological (300463.SZ), has received a medical device registration certificate for its fully automatic cell morphology analyzer, M100, from the Sichuan Drug Administration, enhancing its product lineup in the blood diagnostics field [1] Group 1: Product Development - The newly certified product, M100, is part of the company's blood cell platform, which aims to meet diverse customer needs and application scenarios [1] - The registration of the M100 further improves the product series of the company's blood cell platform [1] Group 2: Competitive Advantage - The new product is expected to strengthen the company's competitive edge in the blood diagnostics and intelligent laboratory sectors [1] - The overall competitiveness and market expansion capabilities of the company are anticipated to improve as a result of this development [1] Group 3: Future Impact - The introduction of the M100 is projected to have a positive impact on the company's future operations [1]

Core Viewpoint - The company, Maike Biological (300463.SZ), has received a medical device registration certificate from the Sichuan Drug Administration for its product, an automatic cell morphology analyzer [1] Group 1 - The product is named "Automatic Cell Morphology Analyzer" [1] - The registration certificate was issued to Maike Medical Electronics Co., Ltd., a wholly-owned subsidiary of the company [1]

Core Viewpoint - The company, Maike Biological (300463.SZ), announced that its wholly-owned subsidiary, Maike Medical Electronics Co., Ltd., has recently received a Medical Device Registration Certificate from the Sichuan Drug Administration for its product, the fully automatic cell morphology analyzer [1] Group 1 - The product is named "fully automatic cell morphology analyzer" [1] - The registration certificate was issued by the Sichuan Drug Administration [1]

Group 1 - The core point of the article is that Maike Biotech (300463) announced the receipt of a medical device registration certificate for its new product, the fully automatic cell morphology analyzer M100, from the Sichuan Drug Administration [1] Group 2 - The registration certificate was issued to Maike Medical Electronics Co., Ltd., a wholly-owned subsidiary of Maike Biotech [1]

证券代码:300463 证券简称:迈克生物 公告编号:2025-107 一、产品注册证具体情况 | 产品名称 | 注册证书 编号 | 注册 类别 | 注册证有效期 | | | | 预期用途 | | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | | | | 产品用于对外周血涂片血细胞的形态 | | 全自动细胞形 | 川械注准 | Ⅱ | 年 2025 8 | 12 | 月 | 日至 | 图像摄取、可视化观察及描述，包括 | | 态学分析仪 | 20252220266 | | 年 7 | 2030 12 | 月 | 日 | 白细胞单细胞图像摄取、初步分类， | | | | | | | | | 红细胞形态描述及血小板数目估算。 | 二、对公司的影响 迈克生物股份有限公司 关于全资子公司新产品取得产品注册证书的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整，没有虚假记载、误导性 陈述或者重大遗漏。 迈克生物股份有限公司（以下简称"公司"）全资子公司迈克医疗电子有限公司于近日收 到四川药品监督管理局颁发的《医疗器械注册证》，具体情况如下： ...

Core Insights - The company has introduced a humanoid intelligent robot named MICO (My Intelligent Cooperator), which represents an innovative exploration in laboratory automation and intelligence [1] - MICO is currently in the early stages of research and development, focusing on validation and scenario adaptation [1] - The future goal is for intelligent robots to enter laboratories and take over more complex and precise tasks [1]

Core Viewpoint - The company is innovating in the field of laboratory automation and intelligence with its humanoid intelligent robot, MICO, which is currently in the early stages of research and development [1] Group 1: Product Development - The humanoid intelligent robot, MICO, is a form of the company's intelligent laboratory partner [1] - MICO aims to explore future solutions for smart laboratories [1] - The product is still in the initial phase of research validation and scenario adaptation [1] Group 2: Future Applications - The intelligent robot is expected to enter laboratories in the future to take over more complex and precise tasks [1]

| 交易日 | (路) 田樹宗族論 | | 融券会重(股) | 融券余额(元) | | --- | --- | --- | --- | --- | | 2025-12-05 | | 2900.0 | 9.79万 | 112.39万 | | 2025-12-04 | | -1.72万 | 9.50万 | 108.20万 | | 2025-12-03 | | 2300.0 | 11.22万 | 128.24万 | | 2025-12-02 | | 3000.0 | 10.99万 | 126.39万 | | 2025-12-01 | | -5200.0 | 10.69万 | 123.36万 | 证券之星消息，12月5日，迈克生物（300463）融资买入642.24万元，融资偿还486.65万元，融资净买入 155.6万元，融资余额3.16亿元，近3个交易日已连续净买入累计626.08万元。 | 交易日 | 融资净买入(元) | 融资余额(元) | 占流通市值比 | | --- | --- | --- | --- | | 2025-12-05 | 155.60万 | 3.16亿 | 5.60% | | 2025-12 ...

Core Insights - The "2025 Chengdu High-tech Zone IVD Industry Supply and Demand Seminar" was held in Chengdu, attracting over 200 participants from leading IVD companies, top academicians, and experts from major hospitals in the Sichuan-Chongqing region, aiming to create a collaborative platform for the IVD industry [1] Group 1: Event Overview - The seminar focused on the theme "Connecting Sichuan and Chongqing, Innovating the Future," aiming to integrate resources across various sectors including government, industry, academia, research, finance, and healthcare [1] - Key activities included policy interpretation, sharing of cutting-edge technologies, supply-demand matching, and project signing, all aimed at fostering high-quality development of the biomedicine industry in the Chengdu-Chongqing economic circle [1] Group 2: Industry Opportunities - Six leading IVD companies from the Sichuan-Chongqing region released an "Opportunity List," covering areas such as IVD reagent R&D, smart manufacturing equipment procurement, and clinical collaborations, with a total value exceeding 10 billion [1] - Collaborative projects were launched between institutions like the Sichuan Academy of Medical Sciences and Chengdu Medical College, focusing on technical challenges and joint talent cultivation [2] Group 3: Collaborative Agreements - Several companies signed "medical-engineering crossover" cooperation agreements, including Chengdu Danodi Medical Technology Co., Ltd. and Chengdu Medical College, focusing on IVD talent training and AI technology development [2] - The event emphasized the integration of AI in IVD, showcasing practical applications in diagnostic reagent development and clinical testing efficiency [2] Group 4: Industry Insights and Discussions - The seminar featured thematic discussions and roundtable forums, addressing topics such as integrated regulatory models for medical device reviews, IVD ecosystem construction from a medical perspective, and international opportunities and challenges [3] - Representatives from various sectors provided insights on regulatory collaboration, industry experience, clinical value, result transformation, financial support, and international pathways for the high-quality development of the Sichuan-Chongqing IVD industry [3]

血型鉴定及不规则抗体筛查质控品系公司新增质控品产品，主要用于监测实验室检测系统的稳定状态， 提高检测质量。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。 迈克生物(300463.SZ)发布公告，公司于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)，该产品为："血型鉴定及不规则抗体筛查质控品"。 ...