Core Viewpoint - The company, Gaoshi Medical (02407), has announced that its subsidiary, Shenzhen Gaoshi Technology Co., Ltd., has officially obtained ISO13485:2016/EN ISO13485:2016 medical device quality management system certification from DEKRA, which covers the entire process of design, development, production, and sales of its products [1] Group 1: Certification Details - The certification encompasses the eye electrophysiological diagnostic system, corneal contact lens, and phacoemulsification vitreous cutting system collection box [1] - DEKRA, established in 1925, is a globally recognized independent non-listed professional inspection, testing, and certification organization [1] Group 2: Importance of ISO13485 - ISO13485 is a specialized quality management system standard for the medical device industry, focusing on patient-centered risk management and comprehensive quality control throughout the product lifecycle [1] - The certification is recognized by major global medical device regulatory bodies, including China's NMPA, the EU's CE, and the US FDA, serving as a core compliance basis [1] Group 3: Implications for the Company - The acquisition of this important qualification represents a significant achievement in the company's quality management system development [1] - It lays a solid foundation for the company to continuously expand into international markets [1]

Core Viewpoint - The company, GaoShi Medical (02407), has received ISO 13485:2016/EN ISO 13485:2016 certification from DEKRA, indicating compliance with international quality management standards for medical devices [1] Group 1: Certification Details - The certification covers the entire process of design, development, production, and sales of the company's ophthalmic electrophysiological diagnostic systems, corneal contact caps, and phacoemulsification vitreous cutting surgical system collection boxes [1] - DEKRA, established in 1925, is a leading independent non-listed professional inspection, testing, and certification organization with a wide industry coverage [1] Group 2: Importance of ISO 13485 - ISO 13485 is a specialized quality management system standard for the medical device industry, focusing on patient-centered risk management and comprehensive quality control throughout the product lifecycle [1] - The certification is recognized by global medical device regulatory bodies such as China's NMPA, the EU's CE, and the US FDA, ensuring that products meet regulatory requirements and are subject to continuous improvement [1] Group 3: Strategic Implications - The acquisition of this important qualification represents a significant achievement in the company's quality management system development, laying a solid foundation for the company to expand into international markets [1]

Core Points - Zhejiang Lino successfully passed the GB/T42061-2022 certification for medical device quality management systems in October 2025, establishing a solid qualification foundation for expanding into high-end markets [1] - The third-party audit assessed the company's quality management system across the entire valve production lifecycle, ensuring compliance with health requirements and traceability from raw materials to testing [1] - The core of the GB/T42061 standard is to ensure product safety through system compliance, shifting the focus of quality management from mere product testing to continuous process compliance [1] Industry Impact - Relevant certification qualifications have become crucial entry barriers in market competition, enabling Zhejiang Lino to accelerate its business due to system compliance [2] - The certification positions the company as one of the few valve manufacturers in the region that meets both medical device quality management system and medical product standards, enhancing its core competitiveness in high-end markets such as food and pharmaceuticals [2]