{"id":46318,"date":"2025-11-11T12:59:21","date_gmt":"2025-11-11T04:59:21","guid":{"rendered":"https:\/\/flcube.com\/?p=46318"},"modified":"2025-11-11T12:59:22","modified_gmt":"2025-11-11T04:59:22","slug":"gaush-meditechs-subsidiary-secures-china-registration-for-integrated-ophthalmic-electrophysiology-system","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=46318","title":{"rendered":"Gaush Meditech\u2019s Subsidiary Secures China Registration for Integrated Ophthalmic Electrophysiology System"},"content":{"rendered":"\n<p><strong>Gaush Meditech Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/2407:HKG\">HKG: 2407<\/a>) announced that its wholly\u2011owned subsidiary <strong>Gaush\u202fTech Ltd.<\/strong> has been issued a <strong>Medical Device Registration Certificate<\/strong> by the <strong>Guangdong Provincial Medical Products Administration<\/strong> for its newly\u2011approved <strong>ophthalmic electrophysiological diagnostic system<\/strong> (Certificate No.\u202fYue\u202fXie\u202fZhu\u202fZhun\u202f20252161439).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-product-overview\">Product Overview<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Feature<\/th><th>Clinical Function<\/th><th>Typical Indications<\/th><\/tr><\/thead><tbody><tr><td><strong>Visual Evoked Potential (VEP)<\/strong><\/td><td>Objective assessment of the optic nerve and entire visual pathway (retinal ganglion \u2192 visual cortex)<\/td><td>Intra\u2011operative monitoring during sellar\u2011region neurosurgery (pituitary adenoma, craniopharyngioma); patients unable to perform subjective acuity tests<\/td><\/tr><tr><td><strong>Electroretinography (ERG)<\/strong><\/td><td>Measures retinal photoreceptor and bipolar cell activity<\/td><td>Screening &amp; diagnosis of retinal dystrophies, diabetic retinopathy, inherited retinal disease<\/td><\/tr><tr><td><strong>Electrooculography (EOG)<\/strong><\/td><td>Evaluates retinal pigment epithelium (RPE) and photoreceptor health<\/td><td>Differential diagnosis of retinitis pigmentosa, Best disease, other RPE\u2011related disorders<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>The system combines all three modalities into a single, compact platform, enabling <strong>comprehensive, objective electrophysiological evaluation<\/strong> of both anterior (optic nerve) and posterior (retina, RPE) visual structures.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone\">Regulatory Milestone<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Authority:<\/strong> Guangdong Provincial Medical Products Administration (GPMPA)<\/li>\n\n\n\n<li><strong>Certificate Number:<\/strong> Yue\u202fXie\u202fZhu\u202fZhun\u202f20252161439<\/li>\n\n\n\n<li><strong>Scope:<\/strong> Class\u202fII medical device \u2013 ophthalmic electrophysiology diagnostics for hospital and specialty eye\u2011care settings across mainland China.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-amp-strategic-implications\">Market &amp; Strategic Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Addressable Market:<\/strong> China\u2019s ophthalmic diagnostics market is projected to exceed <strong>CNY\u202f120\u202fbillion<\/strong> by 2028, driven by an aging population and rising prevalence of retinal disease.<\/li>\n\n\n\n<li><strong>Competitive Edge:<\/strong> Integrated VEP\/ERG\/EOG platform reduces equipment footprint and workflow complexity, offering a <strong>single\u2011point solution<\/strong> versus fragmented multi\u2011vendor setups.<\/li>\n\n\n\n<li><strong>Revenue Outlook:<\/strong> Gaush\u202fMeditech expects the device to contribute <strong>\u2248\u202f15\u202f%<\/strong> of FY\u202f2026 total revenue, with initial sales targeting tertiary eye hospitals in Guangdong, followed by national rollout.<\/li>\n\n\n\n<li><strong>Strategic Fit:<\/strong> The approval aligns with Gaush\u202fMeditech\u2019s broader strategy to expand its <strong>medical\u2011device portfolio<\/strong> beyond its core pharmaceutical business, leveraging existing distribution channels and after\u2011sales service networks.<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding the commercial launch, market potential, and financial impact of Gaush\u202fTech\u2019s ophthalmic electrophysiology system. Actual results may differ due to risks including regulatory changes, market adoption rates, and competitive dynamics.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2025111001196_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2025111001196_c.\"><\/object><a id=\"wp-block-file--media-3de02b27-ec8f-4fe3-bee8-af3bf71769d0\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2025111001196_c.pdf\">2025111001196_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/2025111001196_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-3de02b27-ec8f-4fe3-bee8-af3bf71769d0\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Gaush Meditech Ltd. (HKG: 2407) announced that its wholly\u2011owned subsidiary Gaush\u202fTech Ltd. has been issued&#8230;<\/p>\n","protected":false},"author":1,"featured_media":46335,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,22],"tags":[2002,2003,44,15],"class_list":["post-46318","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-medical-device","tag-gaush-meditech","tag-hkg-2407","tag-ophthalmology","tag-product-approvals"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Gaush Meditech\u2019s Subsidiary Secures China Registration for Integrated Ophthalmic Electrophysiology System - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Gaush Meditech Ltd. 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