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]

格隆汇12月1日丨高视医疗(02407.HK)宣布，公司附属公司深圳高视科技有限公司(「深圳高视科技」) 于近日正式获得由DEKRA签发的符合ISO13485：2016/ENISO13485：2016医疗器械质量管理体系认证 证书(证书编号：4932952)。此次认证全面覆盖了眼电生理诊断系统、角膜接触帽、超乳玻切手术系统 集液盒的设计、开发、生产及销售全流程。 ISO13485是国际标准化组织(「ISO」)发布的医疗器械行业专用质量管理体系标准，聚焦「以患者为中 心」的风险管理与全流程质量控制，是全球医疗器械监管机构(如中国NMPA、欧盟CE、美国FDA等)认 可的核心合规性依据。通过该认证，意味着企业建立了覆盖设计开发、生产、检验、售後等产品全生命 周期的质量管理体系，确保产品符合法规要求并持续改进。 本次重要资质的获得，是公司在质量管理体系建设上的又一重要成果，为公司持续开拓国际市场奠定了 坚实基础。 DEKRA，成立于1925年，为一家全球领先的独立非上市专业检验检测认证机构，覆盖广阔的行业领 域。 ...

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].

Core Viewpoint - The approval of the "Electrophysiological Examination System" by the Guangdong Provincial Drug Administration marks a significant advancement for the company in the ophthalmology medical device sector, enhancing diagnostic capabilities for eye diseases [1][2]. Company Summary - The company's subsidiary, Shenzhen Gaoshi Technology Co., Ltd., has received a medical device registration certificate for its electrophysiological examination system, which includes three main functions: Visual Evoked Potential (VEP), Electroretinography (ERG), and Electrooculography (EOG) [1]. - The VEP function is particularly useful for assessing the visual pathway from the retina to the visual cortex, serving as an objective monitoring tool for brain function in patients unable to cooperate with subjective vision tests [1]. - The ERG function evaluates retinal function and can be used to screen for retinal diseases, while the EOG assesses the function of the retinal pigment epithelium and photoreceptors, aiding in the differentiation of diseases like retinitis pigmentosa [1]. Industry Summary - The electrophysiological examination system has become a routine examination method in ophthalmology, providing pathways for the diagnosis of fundus diseases and offering objective examination methods for retinal function and optic nerve lesions [2]. - This system operates by extracting specific electrophysiological signals emitted by the visual system in response to optical stimuli, enabling accurate early diagnosis of eye diseases [2]. - The technology is characterized by its non-invasive, objective, quantitative, and repeatable nature, playing a crucial role in the diagnosis, differential diagnosis, and prognosis evaluation of eye diseases [2].

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。 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 眼電生理檢查系統獲得中國醫療器械註冊證 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（「高視科技」）之「眼電生理檢查系統」近日已獲得由廣東省藥品監督 管理局批准的醫療器械註冊證。 眼電生理檢查系統已成為眼科常規檢查手段之一，為眼底疾病檢查及診斷提 供了檢查途徑，同時為視網膜功能及視神經病變提供了客觀檢查手段。它是通 過對人體視覺系統在特定的光學信號刺激下發出的特定電生理信號的提取來 實現對眼科疾病準確的早期定位診斷，適用於視通路、視神經、視網膜的疾病 檢測。 ...