Core Viewpoint - The company, Bluestar Medical (002382.SZ), announced that its subsidiary, Biosensors Interventional Technologies Pte. Ltd., has received CE certification for the Lithonic coronary intravascular shockwave treatment system, which is designed to treat severely calcified stenosis areas [1][1]. Group 1 - The Lithonic system is intended for use in areas of severe calcification where balloon dilation or stent expansion is insufficient [1][1]. - The system operates by releasing high-pressure shockwaves to pre-treat calcified lesions, utilizing an electrolytic effect in a solution medium [1][1]. - The technology aims to directly modify calcified lesions and reduce the risk of complications associated with traditional treatment methods, such as vascular perforation and no-reflow phenomena [1][1].

Core Viewpoint - The company, Bluestar Medical (002382.SZ), announced that its subsidiary, Biosensors Interventional Technologies Pte. Ltd., has received CE certification for the Lithonic coronary intravascular shockwave treatment system, which is designed for pre-treatment of severely calcified stenosis, reducing the risk of complications such as vascular perforation and no-reflow [1] Group 1 - The CE certification signifies international recognition of the technology [1] - This certification reinforces the company's technological advantage in the coronary field [1] - The expected positive impact on the company's operational development [1] Group 2 - The sales of medical devices are influenced by market conditions [1] - Investors are advised to exercise caution in their investments [1]

每经AI快讯，1月19日，蓝帆医疗(002382.SZ)公告称，公司心脑血管事业部子公司Biosensors Interventional Technologies Pte. Ltd.的Lithonic™冠脉血管内冲击波治疗系统获得欧盟CE认证。该产品用 于严重钙化狭窄部位的预处理，能减少血管穿孔、无复流等并发症风险。此次认证不仅标志着该技术获 得国际认可，还巩固了公司在冠脉领域的技术优势，预计对公司经营发展产生积极影响。但医疗器械销 售受市场环境影响，投资者需谨慎投资。 ...

Core Viewpoint - The company NuoVance (688105.SH) has recently obtained CE IVDR certification for six nucleic acid testing kits for respiratory pathogens, allowing sales in EU countries and countries recognizing EU CE certification [1] Group 1 - The six nucleic acid testing kits are specifically designed for respiratory pathogens [1] - The CE IVDR certification is a significant regulatory milestone that enables the company to expand its market reach [1] - The certification allows the company to sell its products in the European Union and other countries that accept EU CE certification [1]

Core Viewpoint - The company has received the highest risk level Class D certification from BSI Group The Netherlands B.V. for its iFlash - HIV Combo test kit, marking a significant achievement in its product certification journey [1] Group 1 - The HIV test kit has successfully passed the IVDR CE certification, which is crucial for market entry in the European Union [1] - This certification covers the full range of eight preoperative chemiluminescent test reagents, bringing the total number of certified products to 229 [1] - The certification is expected to positively impact business promotion, although the exact effect on performance remains unpredictable [1]

Core Viewpoint - The company, Pumen Technology (688389.SH), has received the "Medical Device Single Audit Program" (MDSAP) certification from T V S D America Inc., which enhances its credibility in the medical device market [1] Group 1: Certification Details - The certification covers the design, development, production, and distribution of various medical devices, including negative pressure drainage dressing kits, medical negative pressure suction devices, air wave pressure therapy systems, shock wave therapy devices, and drainage bottles [1] - Additionally, the certification includes the design, development, production, and distribution of in vitro diagnostic medical devices such as electrochemiluminescence analyzers and reagents, hemoglobin analyzers and chromatography columns, glycated hemoglobin analyzers and chromatography columns, and immunofluorescence analyzers [1]

Core Viewpoint - Tianyi Medical has received EU MDR certification for multiple products, indicating compliance with the latest EU medical device regulations, which enhances its market access and sales potential in Europe [1][3]. Trading Information Summary - On November 5, 2025, Tianyi Medical's stock closed at 58.8 yuan, up by 5.0%, with a turnover rate of 12.94% and a trading volume of 37,500 shares, resulting in a transaction value of 216 million yuan [1]. - The net inflow of main funds was 18.84 million yuan, while speculative funds saw a net inflow of 13.12 million yuan; however, retail investors experienced a net outflow of 31.97 million yuan [1][3]. Company Announcement Summary - Tianyi Medical has obtained EU MDR certification for products including Extracorporeal Blood Tubing Set, Oral/Enteral Syringe, Oral/Enteral Syringe with ENFit connector, and Arterial-Venous Fistula Needle Set, with the latter being a newly certified product [1][3]. - The certification, effective from November 4, 2025, and valid until January 5, 2028, signifies that the company's products meet the latest EU regulatory requirements, facilitating their promotion and sales in overseas markets [1].

Core Viewpoint - 康泰医学 has recently obtained the CE certificate for its Color Doppler Ultrasound Diagnostic System (CMS1700B, CMS1700C), indicating compliance with EU standards and market entry eligibility, which is expected to positively impact the company's future operations [1]. Company Summary - The product, Color Doppler Ultrasound Diagnostic System (CMS1700B, CMS1700C), has received certification from DNV Product Assurance AS [1]. - The CE certification signifies that the product meets the relevant EU requirements, allowing for access to the European market [1]. - This development is anticipated to have a beneficial effect on the company's future business operations [1].

Core Viewpoint - The company, Pumen Technology (688389), has received FDA 510(k) certification for its semiconductor laser hair removal device, allowing it to enter the U.S. market [1] Company Summary - Pumen Technology announced on August 4 that it has obtained FDA 510(k) certification for its semiconductor laser hair removal device [1]

Core Insights - The company, Pumen Technology, has recently announced that seven of its electrochemical luminescent reagent products have received IVDR CE certification from the EU Notified Body T V Süddeutsche Gruppe [1] Group 1 - The certification indicates compliance with European regulations for in vitro diagnostic medical devices, enhancing the company's marketability in the EU [1] - This achievement may open new opportunities for the company in the European market, potentially increasing sales and market share [1] - The certification process reflects the company's commitment to quality and regulatory standards in the healthcare industry [1]