Core Insights - The article discusses the registration and quality management system assessments for medical devices in Guangdong Province, highlighting various companies and their products that have undergone evaluations and received approvals or required modifications [2][5]. Group 1: Company Registrations - Guangdong Weinuodun Medical Technology Co., Ltd. received approval for its medical ozone therapy device on November 3, 2025 [3]. - Guangdong Baisheng Medical Instrument Co., Ltd. passed the evaluation for high-frequency surgical equipment on November 3, 2025 [3]. - Shenzhen Kefu Biotechnology Co., Ltd. was approved for its continuous glucose monitoring system on November 4, 2025 [3]. - Guangzhou Wanfu Biological Technology Co., Ltd. received approval for its hepatitis B virus nucleic acid testing kit on November 10, 2025 [3]. - Shenzhen Karman Medical Equipment Co., Ltd. was approved for its intracranial pressure sensor and cerebrospinal fluid drainage set on November 12, 2025 [3]. Group 2: Quality Management System Assessments - The Guangdong Provincial Drug Administration is implementing a quality management system assessment for Class II medical devices, with results communicated to applicants via SMS or web queries since May 2022 [5]. - Companies such as Shenzhen Aibo Hechuang Medical Robot Co., Ltd. received approval for their vascular intervention surgery control system on November 27, 2025 [5]. - Guangdong Tiancheng Tianmei Medical Technology Co., Ltd. was approved for absorbable surgical sutures on November 19, 2025 [4].

Group 1 - Lu Kang Pharmaceutical plans to increase capital by 109 million yuan to its wholly-owned subsidiary Bio-Pesticide Company and 27 million yuan to Ze Run Company, aiming to expand its pesticide and sales sectors [1] - Hui Green Ecology intends to sell two properties in Ningbo for 12.52 million yuan, expecting a net profit impact of approximately 6.23 million yuan from the transaction [2] - Tianyuan Co., Ltd. plans to invest 185 million yuan in an intelligent upgrade project for its titanium dioxide production facilities [3] Group 2 - Metro Design has received approval from the Shenzhen Stock Exchange for its share issuance to acquire 100% equity of Guangzhou Metro Engineering Consulting Co., Ltd. for 511 million yuan [4] - South Network Energy announced a mid-term profit distribution plan for 2025, proposing a cash dividend of 0.07 yuan per 10 shares [5] - Qibin Group plans to establish two wholly-owned subsidiaries in Shenzhen with a registered capital of 100 million yuan each [6] Group 3 - All New Good received an administrative regulatory decision from the Shenzhen Securities Regulatory Bureau due to issues in financial accounting and information disclosure [7] - Luokai Co., Ltd. announced that its shareholders plan to reduce their holdings by up to 3% of the company's shares [8][9] - Jincheng Pharmaceutical's actual controller received an administrative penalty from the CSRC for stock manipulation, leading to the resignation of the chairman [10] Group 4 - Yicheng New Energy intends to acquire a 7.69% stake in Kaifeng Times for 10 million yuan, enhancing its strategic development [11] - Yujing Co., Ltd. signed a sales contract worth approximately 28.6 million USD with an overseas photovoltaic company [12] - Nuocheng Jianhua's TRK inhibitor, Zoltracitinib, has been approved for market entry in China [13] Group 5 - Nandu Power announced that its controlling shareholder is planning a change in control, leading to a temporary suspension of its stock [14] - Xinxing Casting plans to acquire 100% equity of China Resources Steel for 1.244 billion yuan to focus on special steel development [15] - Xinlitai is planning to issue H-shares and list on the Hong Kong Stock Exchange [16] Group 6 - Blue Fan Medical's subsidiary received approval for a new medical device, the coronary artery scoring balloon dilation catheter [18] - China Iron & Steel plans to establish a joint venture with several companies to provide new energy transportation solutions with a registered capital of 500 million yuan [19] - Jifeng Technology intends to sign a cooperation framework agreement with Dongtai Lianfei for a total transaction amount not exceeding 100 million yuan [20] Group 7 - Zhongwei Electronics announced a change in its actual controller, with stock resuming trading [21] - Weihong Co., Ltd. plans to reduce its holdings by up to 1.15% of the company's shares [22] - Te Fa Information received a criminal judgment related to a fraud case involving the acquisition of Shenzhen Te Fa Dongzhi Technology Co., Ltd. [23] Group 8 - Sunshine Dairy's controlling shareholder's concerted action plans to reduce holdings by up to 3% of the company's shares [24] - Meikailong reported that Taobao Holdings and New Retail Fund collectively reduced their H-shares by 30.616 million shares [25] - Xinjubang plans to issue H-shares and apply for listing on the Hong Kong Stock Exchange [26] Group 9 - Beite Technology's application for issuing A-shares to specific objects has been approved by the Shanghai Stock Exchange [28] - Victory Energy's controlling shareholder is planning a change in control, with stock resuming trading [29] - Jiutian Pharmaceutical signed a patent and technology transfer agreement for a small molecule analgesic drug project, with a total transfer fee not exceeding 400 million yuan [29]

Core Viewpoint - The approval of the "Coronary Scoring Balloon Dilatation Catheter" by the National Medical Products Administration (NMPA) represents a significant advancement for the company in providing effective solutions for complex coronary artery diseases [1][2]. Product Information - The product, named "Star Scar," features a unique spiral triangular scoring wire that allows for 360° efficient pressure-focused dilation [1]. - It is the only coronary scoring balloon with up to four scoring wires, providing a larger scoring area and a rated burst pressure (RBP) of up to 20 atm, enhancing safety during expansion [1]. - The device is particularly advantageous for treating calcified and high-resistance complex lesions, offering a safer and more ideal choice for coronary intervention [1]. Impact on the Company - The successful approval of the Star Scar catheter not only provides a precise and efficient pre-dilation option for complex coronary artery lesions but also completes the strategic puzzle for the company's cardiovascular division in constructing a "PCI optimization full-link solution" [2]. - This development is expected to positively influence the company's operational growth by enabling a comprehensive solution for both simple and complex lesions in PCI treatments [2].

Core Viewpoint - Blue Sail Medical (002382.SZ) has received the medical device registration certificate from the National Medical Products Administration (NMPA) for its self-developed and produced Class III medical device, the "Coronary Scoring Balloon Dilatation Catheter" (branded as "Star Scar™") [1] Group 1: Product Features - The Star Scar™ catheter features a unique spiral-wound triangular scoring wire that allows for 360° efficient pressure-focused dilation [1] - It is the market's highest with four scoring wires, providing a larger scoring area and a rated burst pressure (RBP) of up to 20 atm, which offers a higher safety expansion margin [1] - The device excels in reducing the incidence of dissection and optimizing vascular preparation, particularly advantageous for complex lesions such as calcification [1] Group 2: Market Implications - The introduction of the Star Scar™ catheter provides a safer and more ideal option for coronary intervention treatments [1]

Core Viewpoint - The company, Bluestar Medical (002382.SZ), has successfully obtained a medical device registration certificate from the National Medical Products Administration (NMPA) for its self-developed and produced Class III medical device, the "Coronary Artery Scoring Balloon Dilatation Catheter" Group 1 - The product is developed and manufactured by the company's subsidiary, Shandong Jiwei Medical Products Co., Ltd. [1] - The approval signifies a significant milestone for the company's cardiovascular division [1]

Core Viewpoint - Blue Sail Medical (002382.SZ) announced that its subsidiary, Shandong Jiwei Medical Products Co., Ltd., has successfully developed and produced a Class III medical device, the "Coronary Angioplasty Balloon Catheter," which has received the medical device registration certificate from the National Medical Products Administration (NMPA) [1] Group 1 - The product is categorized as a Class III medical device, indicating its high risk and the need for stringent regulatory oversight [1] - The approval from NMPA marks a significant milestone for the company in expanding its product offerings in the cardiovascular sector [1] - This development may enhance the company's competitive position in the medical device market, particularly in cardiovascular treatments [1]