FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年12月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 高视医疗科技有限公司 (於開曼群島註冊成立的有限責任公司) 呈交日期: 2026年1月2日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02407 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 500,000,000 | USD | | 0.0001 USD | | 50,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 500,000,000 | USD | | 0.0001 USD | | 50,000 | 本月底法定/ ...

Group 1 - The core point of the article highlights that southbound funds have reduced their holdings in Gaoshi Medical (02407.HK) by 2,800 shares on December 22, with a total net reduction of 30,700 shares over the last five trading days and 155,200 shares over the last twenty trading days [1] - As of now, southbound funds hold 5,852,700 shares of Gaoshi Medical, which represents 3.95% of the company's total issued ordinary shares [1] Group 2 - Gaoshi Medical Technology Co., Ltd. primarily engages in the research, development, manufacturing, and sales of ophthalmic medical devices and consumables [1] - The company operates through four segments: proprietary products, distribution, technical services, and others [1] - The proprietary products segment develops and produces surgical equipment and related software, intraocular lenses, diagnostic and treatment equipment for eye diseases, and related consumables [1] - The distribution segment sells multifunctional diagnostic equipment, fundus diagnostic, surgical, and treatment equipment produced by other ophthalmic medical device manufacturers, along with related consumables [1] - The technical services segment provides warranty services, maintenance services, and consumables used for after-sales services [1] - The other segment mainly includes granting intellectual property rights and providing clinical research organization-related services [1]

Group 1 - The core point of the news is that Southbound funds have reduced their holdings in Gaoshi Medical (02407.HK) by 2,900 shares on December 9, 2025, marking a continuous trend of reduction over the past trading days [1] - In the last 5 trading days, Southbound funds have cumulatively reduced their holdings by 70,500 shares, while in the last 20 trading days, the total reduction amounts to 151,000 shares [1] - As of now, Southbound funds hold 5,908,200 shares of Gaoshi Medical, which represents 3.99% of the company's total issued ordinary shares [1] Group 2 - Gaoshi Medical Technology Co., Ltd. is primarily engaged in the research, development, manufacturing, and sales of ophthalmic medical devices and consumables [2] - The company operates through four segments: proprietary products, distribution, technical services, and other services, including clinical research organization services [2] - The proprietary products segment develops and produces surgical equipment, related software, intraocular lenses, and diagnostic and treatment equipment for eye diseases [2]

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 Viewpoint - The company, Gaoshi Medical (02407.HK), has officially obtained ISO13485:2016/ENISO13485:2016 certification for its subsidiary, Shenzhen Gaoshi Technology Co., Ltd., which enhances its quality management system for medical devices [1] Group 1: Certification Details - The certification covers the entire process of design, development, production, and sales of 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 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 signifies that the company has established a quality management system that meets regulatory requirements and ensures 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 [1] - This certification lays a solid foundation for the company to continuously expand into international markets [1]

Gaush Meditech Ltd 高視醫療科技有限公司 （ 於 開 曼 群 島 註 冊 成 立 的 有 限 責 任 公 司 ） （股 份 代 號：2407） 自願公告 深圳高視科技獲得醫療器械質量管理體系國際認證證書 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或 因倚賴該等內容而引致的任何損失承擔任何責任。 本公告由高視醫療科技有限公司（「本公司」，連同其附屬公司統稱「本集團」） 自願作出，以告知本公司股東及潛在投資者有關本集團的最新業務發展。 本 公 司 董 事（「董 事」）會（「董事會」）欣 然 宣 佈，本 公 司 附 屬 公 司 深 圳 高 視 科 技 有 限 公 司（「深圳高視科技」）於 近 日 正 式 獲 得 由DEKRA簽發的符合ISO 13485：2016/EN ISO 13485：2016醫療器械質量管理體系認證證書（證書編號： 4932952）。此次認證全面覆蓋了眼電生理診斷系統、角膜接觸帽、超乳玻切手 術系統集液盒的設計、開發、生產及銷售全流程。 DEKRA，成立於19 ...

FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年11月30日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 高视医疗科技有限公司 (於開曼群島註冊成立的有限責任公司) 呈交日期: 2025年12月1日 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02407 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 500,000,000 | USD | 0.0001 | USD | | 50,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 500,000,000 | USD | 0.0001 | USD | | 50,000 | 本月底法定/註冊股本總額： USD ...

Core Viewpoint - Southbound funds have reduced their holdings in Gaoshi Medical (02407.HK) by 6,100 shares on November 12, 2025, marking a continued trend of net reductions over recent trading days [1] Group 1: Shareholding Changes - In the last 5 trading days, southbound funds have reduced their holdings for 5 days, with a total net reduction of 40,200 shares [1] - Over the last 20 trading days, there has been a total net reduction of 332,500 shares, with reductions occurring on all 20 days [1] - As of November 12, 2025, southbound funds hold 6,052,800 shares of Gaoshi Medical, representing 4.08% of the company's total issued ordinary shares [1] Group 2: Company Overview - Gaoshi Medical Technology Co., Ltd. primarily engages in ophthalmic medical business, operating through four segments: self-owned products, distribution, technical services, and others [2] - The self-owned products segment develops and manufactures surgical equipment, related software, intraocular lenses, and diagnostic and treatment equipment for eye diseases [2] - The distribution segment sells branded ophthalmic medical devices and consumables, while the technical services segment provides warranty, maintenance, and after-sales services [2] - The company's products are widely used in the examination, treatment, and correction of various ophthalmic sub-specialties, including fundus diseases, cataracts, glaucoma, refraction, and pediatric ophthalmology [2]

Core Viewpoint - The announcement highlights that Gaoshi Medical's subsidiary, Shenzhen Gaoshi Technology Co., Ltd., has received approval for its "Electrophysiological Examination System" from the Guangdong Provincial Drug Administration, marking a significant advancement in ophthalmic diagnostic tools [1][2]. Group 1: Product Features - The approved system includes three main functions: Visual Evoked Potential (VEP), Electroretinography (ERG), and Electrooculography (EOG) [1]. - VEP is primarily used for assessing the visual pathway function from the retinal ganglion cells to the visual cortex, serving as an objective monitoring tool for patients unable to cooperate with subjective vision tests [1]. - ERG evaluates retinal function, particularly in detecting retinal diseases, while EOG assesses the function of the retinal pigment epithelium and photoreceptors, aiding in the differentiation of diseases like retinitis pigmentosa [1]. Group 2: Clinical Applications - The Electrophysiological Examination System has become a routine examination method in ophthalmology, providing pathways for the diagnosis of fundus diseases and objective examination methods for retinal function and optic nerve lesions [2]. - The system's technology extracts specific electrophysiological signals from the visual system in response to optical stimuli, enabling accurate early diagnosis of ocular diseases [2]. - Its non-invasive, objective, quantitative, and repeatable characteristics make it significant for diagnosing and differentiating diseases, evaluating treatment efficacy, and objectively assessing visual function [2].