{"id":65450,"date":"2026-06-17T16:09:27","date_gmt":"2026-06-17T07:09:27","guid":{"rendered":"https:\/\/japanir.jp\/en\/ir\/7775-20260617-01_wp_basic\/"},"modified":"2026-07-12T12:11:25","modified_gmt":"2026-07-12T03:11:25","slug":"7775-20260617-01_wp_basic","status":"publish","type":"ir_release","link":"https:\/\/japanir.jp\/en\/company\/company-7775\/ir\/7775-20260617-01_wp_basic\/","title":{"rendered":"Status of MDR Application Approval for the European Expansion of Quadec Amy PCA (Progress of Disclosure 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center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"jir_stock_code":"7775","jir_company_name":"Daiken Iki Co., Ltd.","jir_importance":"\u2605\u2605\u2605\u2606\u2606","jir_publication_date":"2026-06-17","jir_source_link":"[Placeholder]","jir_short_summary":"Report on MDR certification status for the European rollout of QuDEC Aim\u00e9 PCA, upcoming schedule, and regulatory filings outside Europe. Although the timing of MDR certification is undecided, we plan to file within this fiscal year. The impact on this fiscal year's results is expected to be minor.","jir_summary":"### Current status of performance and regulatory compliance\nReport on the status of European MDR certification review for the European rollout of QuDEC Aim\u00e9 PCA. Review of technical documentation, biological safety, and aseptic assurance is complete; clinical evaluation remains the main outstanding item. Working with external institutions to progress responses including a PMCF plan. Certification timing is uncertain and depends on the review process, but filing is planned within this fiscal year.\n\n### Initiatives in regions outside Europe\nBeyond Europe, regulatory filings for Vietnam in Asia and regulatory filing preparation in South America are advancing. We will respond appropriately to regional regulatory requirements and proceed with overseas expansion in a phased manner.","jir_financial_highlights":"Impact on this fiscal year's results: Unknown\nStatus as of October 31, 2024: Unknown","jir_category":"Other","jir_hashtags":"#Daiken Iki Co., Ltd., #IRDisclosure, #JapanStocks","jir_key_figures":"Clinical evaluation responses including PMCF plan formulation\nEuropean MDR certification timing is undecided\nMDR filing planned within this fiscal year","jir_meta_title":"\u3010Daiken Iki\u3011MDR filing progress and European expansion status | June 2026","jir_meta_description":"Summary of Daiken Iki's European MDR filing progress for the \u30af\u30fc\u30c7\u30c3\u30af\u30a8\u30a4\u30df\u30fc PCA and regulatory filings outside Europe. Certification timing is undecided, but filings are planned within this fiscal year. Impact this term is expected to be minor.","jir_og_title":"Daiken Iki MDR filing progress and European expansion status","jir_og_description":"Report on the current status of European MDR filing and overseas expansion plans. Certification timing is undecided; continuation of clinical evaluation preparations including the PMCF plan.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":58412,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"disclosure_update","footnotes":""},"sector":[],"importance":[],"class_list":["post-65450","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Status of MDR Application Approval for the European Expansion of Quadec Amy PCA (Progress of Disclosure Items) - Japan IR<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/japanir.jp\/en\/company\/company-7775\/ir\/7775-20260617-01_wp_basic\/\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/japanir.jp\/en\/company\/company-7775\/ir\/7775-20260617-01_wp_basic\/\",\"url\":\"https:\/\/japanir.jp\/en\/company\/company-7775\/ir\/7775-20260617-01_wp_basic\/\",\"name\":\"Status of MDR Application Approval for the European Expansion of Quadec Amy PCA (Progress of Disclosure Items) - 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