{"id":150693,"date":"2018-10-04T10:35:43","date_gmt":"2018-10-04T10:35:43","guid":{"rendered":"https:\/\/www.moor.co.uk\/support\/standards-approvals\/"},"modified":"2026-09-07T12:10:54","modified_gmt":"2026-09-07T12:10:54","slug":"standards-approvals","status":"publish","type":"m_support","link":"https:\/\/www.moor.co.uk\/en-eu\/support\/standards-approvals\/","title":{"rendered":"Standards & Approvals"},"content":{"rendered":"

Standards & Approvals<\/h1>\n

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

Moor Instruments in the design and manufacture of medical devices has been assessed and certified as meeting the requirements of ISO13485:2016<\/a> and 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

Medical Devices<\/h2>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Device<\/span><\/th>\nRegion of Sale<\/span><\/th>\nMedical Device CE Marking<\/span><\/th>\nFDA 510(k)<\/span><\/th>\nLab Equipment CE Marking<\/span><\/th>\n<\/tr>\n<\/thead>\n
moorLDI2-BI<\/td>\nWorldwide<\/td>\nYes \u2013 Class IIa<\/td>\nYes (K060976)<\/td>\nNo<\/td>\n<\/tr>\n
moorLDLS-BI<\/td>\nWorldwide<\/td>\nYes \u2013 Class IIa<\/td>\nYes (K132163)<\/td>\nNo<\/td>\n<\/tr>\n
moorFLPI-2<\/td>\nWorldwide excluding EU & UK<\/td>\nNo<\/td>\nYes (K122943)<\/td>\nNo<\/td>\n<\/tr>\n
MS2-MKII<\/td>\nWorldwide excluding USA<\/td>\nYes \u2013 Class I<\/td>\nNo<\/td>\nNo<\/td>\n<\/tr>\n
MS3B-FLPI-H<\/td>\nWorldwide excluding USA<\/td>\nYes \u2013 Class I<\/td>\nNo<\/td>\nNo<\/td>\n<\/tr>\n
MS3B-FLPI-F<\/td>\nWorldwide excluding EU, UK, & USA<\/td>\nNo<\/td>\nNo<\/td>\nNo<\/td>\n<\/tr>\n
MS3B-LDLS-H<\/td>\nWorldwide excluding USA<\/td>\nYes \u2013 Class I<\/td>\nNo<\/td>\nNo<\/td>\n<\/tr>\n
MS4<\/td>\nWorldwide excluding USA<\/td>\nYes \u2013 Class I<\/td>\nNo<\/td>\nNo<\/td>\n<\/tr>\n
moorLDI2-VR<\/td>\nWorldwide excluding EU & UK<\/td>\nNo<\/td>\nYes (K152749)<\/td>\nNo<\/td>\n<\/tr>\n
moorLDI2-IR<\/td>\nWorldwide excluding EU & UK<\/td>\nNo<\/td>\nYes (K152749)<\/td>\nNo<\/td>\n<\/tr>\n
moorLDI2-HIR<\/td>\nWorldwide excluding EU & UK<\/td>\nNo<\/td>\nYes (K152749)<\/td>\nNo<\/td>\n<\/tr>\n
BS1<\/td>\nWorldwide excluding EU, UK, & USA<\/td>\nNo<\/td>\nNo<\/td>\nNo<\/td>\n<\/tr>\n
DS2<\/td>\nWorldwide excluding EU, UK, & USA<\/td>\nNo<\/td>\nNo<\/td>\nNo<\/td>\n<\/tr>\n
moorVMS-LDF<\/td>\nWorldwide excluding EU & UK<\/td>\nNo<\/td>\nYes (K083082)<\/td>\nNo<\/td>\n<\/tr>\n
moorVMS-PRES<\/td>\nWorldwide excluding EU & UK<\/td>\nNo<\/td>\nYes (K102433)<\/td>\nNo<\/td>\n<\/tr>\n
moorVMS-OXY<\/td>\nWorldwide excluding EU & UK<\/td>\nNo<\/td>\nYes (K112826)<\/td>\nNo<\/td>\n<\/tr>\n
moorVMS-NIRS<\/td>\nWorldwide excluding EU, UK, & USA<\/td>\nNo<\/td>\nNo<\/td>\nNo<\/td>\n<\/tr>\n
moorVMS-HEAT<\/td>\nWorldwide excluding EU, UK, & USA<\/td>\nNo<\/td>\nNo<\/td>\nNo<\/td>\n<\/tr>\n
moorVMS-ION<\/td>\nWorldwide excluding EU, UK, & USA<\/td>\nNo<\/td>\nNo<\/td>\nNo<\/td>\n<\/tr>\n
moorVMS-PC<\/td>\nWorldwide excluding EU, UK, & USA<\/td>\nNo<\/td>\nNo<\/td>\nNo<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

<\/h2>\n

Note:<\/strong> Worldwide sale is subject to compliance with local regulatory requirements.<\/p>\n

Laboratory Equipment \u2013 non medical use only<\/h2>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Device<\/span><\/th>\nRegion of Sale<\/span><\/th>\nMedical Device CE Marking<\/span><\/th>\nFDA 510(k)<\/span><\/th>\nLab Equipment CE Marking<\/span><\/th>\n<\/tr>\n<\/thead>\n
moorLDI2-VR-EU<\/td>\nEU & UK Only<\/td>\nNo<\/td>\nNo<\/td>\nYes<\/td>\n<\/tr>\n
moorLDI2-IR-EU<\/td>\nEU & UK Only<\/td>\nNo<\/td>\nNo<\/td>\nYes<\/td>\n<\/tr>\n
moorLDI2-HIR-EU<\/td>\nEU & UK Only<\/td>\nNo<\/td>\nNo<\/td>\nYes<\/td>\n<\/tr>\n
BS1-EU<\/td>\nEU & UK Only<\/td>\nNo<\/td>\nNo<\/td>\nNo*<\/td>\n<\/tr>\n
DS2-EU<\/td>\nEU & UK Only<\/td>\nNo<\/td>\nNo<\/td>\nNo*<\/td>\n<\/tr>\n
moorO2<\/sub>Flo-2<\/td>\nWorldwide<\/td>\nNo<\/td>\nNo<\/td>\nYes<\/td>\n<\/tr>\n
moorLAB-LDF<\/td>\nEU & UK Only<\/td>\nNo<\/td>\nNo<\/td>\nYes<\/td>\n<\/tr>\n
moorLAB-PRES<\/td>\nEU & UK Only<\/td>\nNo<\/td>\nNo<\/td>\nYes<\/td>\n<\/tr>\n
moorLAB-OXY<\/td>\nEU & UK Only<\/td>\nNo<\/td>\nNo<\/td>\nYes<\/td>\n<\/tr>\n
moorLAB-NIRS<\/td>\nEU & UK Only<\/td>\nNo<\/td>\nNo<\/td>\nYes<\/td>\n<\/tr>\n
moorLAB-HEAT<\/td>\nEU & UK Only<\/td>\nNo<\/td>\nNo<\/td>\nYes<\/td>\n<\/tr>\n
moorLAB-ION<\/td>\nEU & UK Only<\/td>\nNo<\/td>\nNo<\/td>\nYes<\/td>\n<\/tr>\n
moorLAB-NIBP<\/td>\nWorldwide<\/td>\nNo<\/td>\nNo<\/td>\nYes<\/td>\n<\/tr>\n
moorLAB-PC<\/td>\nEU & UK Only<\/td>\nNo<\/td>\nNo<\/td>\nNo*<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

<\/h2>\n

Note:<\/strong> Worldwide sale is subject to compliance with local regulatory requirements.<\/p>\n

*There are no relevant EU directives or regulations for these devices.<\/p>\n","protected":false},"featured_media":0,"menu_order":0,"template":"","tags":[],"class_list":["post-150693","m_support","type-m_support","status-publish","hentry"],"acf":[],"yoast_head":"\nStandards & Approvals - Moor Instruments<\/title>\n<meta name=\"description\" content=\"Moor Instruments is ISO 13485 certified and CE marked for medical device quality and safety. Explore our FDA-registered products.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.moor.co.uk\/en-eu\/support\/standards-approvals\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Standards & Approvals - Moor Instruments\" \/>\n<meta property=\"og:description\" content=\"Moor Instruments is ISO 13485 certified and CE marked for medical device quality and safety. Explore our FDA-registered products.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.moor.co.uk\/en-eu\/support\/standards-approvals\/\" \/>\n<meta property=\"og:site_name\" content=\"Moor Instruments\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/MoorInstruments\" \/>\n<meta property=\"article:modified_time\" content=\"2026-09-07T12:10:54+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:site\" content=\"@moor_hq\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.moor.co.uk\/en-eu\/support\/standards-approvals\/\",\"url\":\"https:\/\/www.moor.co.uk\/en-eu\/support\/standards-approvals\/\",\"name\":\"Standards & Approvals - Moor Instruments\",\"isPartOf\":{\"@id\":\"https:\/\/www.moor.co.uk\/#website\"},\"datePublished\":\"2018-10-04T10:35:43+00:00\",\"dateModified\":\"2026-09-07T12:10:54+00:00\",\"description\":\"Moor Instruments is ISO 13485 certified and CE marked for medical device quality and safety. Explore our FDA-registered products.\",\"breadcrumb\":{\"@id\":\"https:\/\/www.moor.co.uk\/en-eu\/support\/standards-approvals\/#breadcrumb\"},\"inLanguage\":\"en-EU\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.moor.co.uk\/en-eu\/support\/standards-approvals\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.moor.co.uk\/en-eu\/support\/standards-approvals\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.moor.co.uk\/en-eu\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Standards & Approvals\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.moor.co.uk\/#website\",\"url\":\"https:\/\/www.moor.co.uk\/\",\"name\":\"Moor Instruments\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\/\/www.moor.co.uk\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.moor.co.uk\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-EU\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.moor.co.uk\/#organization\",\"name\":\"Moor Instruments\",\"url\":\"https:\/\/www.moor.co.uk\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-EU\",\"@id\":\"https:\/\/www.moor.co.uk\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.moorclinical.com\/wp-content\/uploads\/2018\/10\/logo-30.png\",\"contentUrl\":\"https:\/\/www.moorclinical.com\/wp-content\/uploads\/2018\/10\/logo-30.png\",\"width\":298,\"height\":49,\"caption\":\"Moor Instruments\"},\"image\":{\"@id\":\"https:\/\/www.moor.co.uk\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.facebook.com\/MoorInstruments\",\"https:\/\/x.com\/moor_hq\",\"https:\/\/www.linkedin.com\/company\/2523249\",\"https:\/\/www.youtube.com\/user\/MoorInstruments\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Standards & Approvals - Moor Instruments","description":"Moor Instruments is ISO 13485 certified and CE marked for medical device quality and safety. Explore our FDA-registered products.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.moor.co.uk\/en-eu\/support\/standards-approvals\/","og_locale":"en_US","og_type":"article","og_title":"Standards & Approvals - Moor Instruments","og_description":"Moor Instruments is ISO 13485 certified and CE marked for medical device quality and safety. Explore our FDA-registered products.","og_url":"https:\/\/www.moor.co.uk\/en-eu\/support\/standards-approvals\/","og_site_name":"Moor Instruments","article_publisher":"https:\/\/www.facebook.com\/MoorInstruments","article_modified_time":"2026-09-07T12:10:54+00:00","twitter_card":"summary_large_image","twitter_site":"@moor_hq","twitter_misc":{"Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.moor.co.uk\/en-eu\/support\/standards-approvals\/","url":"https:\/\/www.moor.co.uk\/en-eu\/support\/standards-approvals\/","name":"Standards & Approvals - Moor Instruments","isPartOf":{"@id":"https:\/\/www.moor.co.uk\/#website"},"datePublished":"2018-10-04T10:35:43+00:00","dateModified":"2026-09-07T12:10:54+00:00","description":"Moor Instruments is ISO 13485 certified and CE marked for medical device quality and safety. Explore our FDA-registered products.","breadcrumb":{"@id":"https:\/\/www.moor.co.uk\/en-eu\/support\/standards-approvals\/#breadcrumb"},"inLanguage":"en-EU","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.moor.co.uk\/en-eu\/support\/standards-approvals\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.moor.co.uk\/en-eu\/support\/standards-approvals\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.moor.co.uk\/en-eu\/"},{"@type":"ListItem","position":2,"name":"Standards & Approvals"}]},{"@type":"WebSite","@id":"https:\/\/www.moor.co.uk\/#website","url":"https:\/\/www.moor.co.uk\/","name":"Moor Instruments","description":"","publisher":{"@id":"https:\/\/www.moor.co.uk\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.moor.co.uk\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-EU"},{"@type":"Organization","@id":"https:\/\/www.moor.co.uk\/#organization","name":"Moor Instruments","url":"https:\/\/www.moor.co.uk\/","logo":{"@type":"ImageObject","inLanguage":"en-EU","@id":"https:\/\/www.moor.co.uk\/#\/schema\/logo\/image\/","url":"https:\/\/www.moorclinical.com\/wp-content\/uploads\/2018\/10\/logo-30.png","contentUrl":"https:\/\/www.moorclinical.com\/wp-content\/uploads\/2018\/10\/logo-30.png","width":298,"height":49,"caption":"Moor Instruments"},"image":{"@id":"https:\/\/www.moor.co.uk\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/MoorInstruments","https:\/\/x.com\/moor_hq","https:\/\/www.linkedin.com\/company\/2523249","https:\/\/www.youtube.com\/user\/MoorInstruments"]}]}},"_links":{"self":[{"href":"https:\/\/www.moor.co.uk\/en-eu\/wp-json\/wp\/v2\/m_support\/150693","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.moor.co.uk\/en-eu\/wp-json\/wp\/v2\/m_support"}],"about":[{"href":"https:\/\/www.moor.co.uk\/en-eu\/wp-json\/wp\/v2\/types\/m_support"}],"version-history":[{"count":20,"href":"https:\/\/www.moor.co.uk\/en-eu\/wp-json\/wp\/v2\/m_support\/150693\/revisions"}],"predecessor-version":[{"id":160307,"href":"https:\/\/www.moor.co.uk\/en-eu\/wp-json\/wp\/v2\/m_support\/150693\/revisions\/160307"}],"wp:attachment":[{"href":"https:\/\/www.moor.co.uk\/en-eu\/wp-json\/wp\/v2\/media?parent=150693"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.moor.co.uk\/en-eu\/wp-json\/wp\/v2\/tags?post=150693"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}