{"id":26744,"date":"2019-12-11T14:09:20","date_gmt":"2019-12-11T14:09:20","guid":{"rendered":"https:\/\/www.moorclinical.com\/support\/standards-approvals\/"},"modified":"2024-12-03T16:23:51","modified_gmt":"2024-12-03T16:23:51","slug":"standards-approvals","status":"publish","type":"m_support","link":"https:\/\/www.moorclinical.com\/en-us\/support\/standards-approvals\/","title":{"rendered":"Standards &#038; Approvals"},"content":{"rendered":"<p>It is our policy to design and manufacture medical and life science equipment of the highest quality and reliability to meet the requirements of our customers.<\/p>\n<p>Moor Instruments in the design and manufacture of medical devices has been assessed and certified as meeting the requirements of\u00a0<a href=\"https:\/\/www.moorclinical.com\/wp-content\/uploads\/2024\/12\/GBPC_012586_GenericCertificate_Final-13485-Issue-25.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">ISO13485:2016<\/a> and <a href=\"https:\/\/www.moorclinical.com\/wp-content\/uploads\/2019\/12\/EC-Directive-93-42-EEC-GB19-964564-Issue-2-DISTRIBUTOR-AND-WEB-COPY.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Directive 93\/42\/EEC by Notified Body 1639<\/a> due to meeting the requirements of Regulation (EU) 2023\/607, the CE certificate GB19\/964564 remains valid. By working to strict quality control procedures, we ensure product safety and reliability.<\/p>\n<p><strong>Moor Instruments CE marked products<\/strong><\/p>\n<p>All commercially available products are CE (European Conformity) marked.<\/p>\n<p>The following products are registered with the Notified Body and CE1639\u00a0marked :-<\/p>\n<ul>\n<li>moorLDI2-BI Laser Doppler Burns Imager<\/li>\n<li>moorLDLS-BI Laser Doppler Burns Imager<\/li>\n<\/ul>\n<p><strong>Moor Instruments USA FDA 510(k) registered products<\/strong><\/p>\n<p>The following Moor Instruments products are registered with the USA FDA (Food and Drug Administration) under a 510(k) premarket submission:-<\/p>\n<table class=\"table table-bordered\">\n<tbody>\n<tr>\n<td style=\"background-color: #0b87c9;\"><span style=\"color: #ffffff;\"><strong>Device Name<\/strong><\/span><\/td>\n<td style=\"background-color: #0b87c9;\"><span style=\"color: #ffffff;\"><strong>510(K) Number<\/strong><\/span><\/td>\n<\/tr>\n<tr>\n<td>moorLDI2-BI Laser Doppler Burns Imager<\/td>\n<td>K060976<\/td>\n<\/tr>\n<tr>\n<td>moorLDLS-BI Laser Doppler Burns Imager<\/td>\n<td>K132163<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":0,"parent":0,"menu_order":0,"template":"","tags":[],"class_list":["post-26744","m_support","type-m_support","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.10 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Standards &amp; Approval - Burn Assessment - Moor Instruments<\/title>\n<meta name=\"description\" content=\"It is our policy to design and manufacture medical and life science equipment of the highest quality and reliability. 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