{"id":448,"date":"2021-03-22T21:14:32","date_gmt":"2021-03-22T20:14:32","guid":{"rendered":"http:\/\/injex.asmusundhock.de\/downloads\/zertifikate\/"},"modified":"2026-03-20T18:59:26","modified_gmt":"2026-03-20T17:59:26","slug":"certificates","status":"publish","type":"page","link":"https:\/\/www.injex.de\/en\/downloads\/certificates\/","title":{"rendered":"Certificates"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row][vc_column]\n\t\t\t\t<p class=\"rs-p-wp-fix\"><\/p>\n\t\t\t\t<sr7-module data-alias=\"zertifikate-11\" data-id=\"20\" id=\"SR7_20_1\" class=\"rs-ov-hidden\" data-version=\"6.7.58\">\n\t\t\t\t\t<sr7-adjuster><\/sr7-adjuster>\n\t\t\t\t\t<sr7-content>\n\t\t\t\t\t\t<sr7-slide id=\"SR7_20_1-44\" data-key=\"44\">\n\t\t\t\t\t\t\t<sr7-bg id=\"SR7_20_1-44-4\" class=\"sr7-layer\"><noscript><img decoding=\"async\" src=\"http:\/\/www.injex.de\/wp-content\/uploads\/2021\/03\/injex-about-start.jpg\" alt=\"\" title=\"injex about start\"><\/noscript><\/sr7-bg>\n\t\t\t\t\t\t\t<sr7-txt id=\"SR7_20_1-44-1\" class=\"sr7-layer\">CERTIFICATES<\/sr7-txt>\n\t\t\t\t\t\t\t<sr7-txt id=\"SR7_20_1-44-3\" class=\"sr7-layer\">View more<\/sr7-txt>\n\t\t\t\t\t\t<\/sr7-slide>\n\t\t\t\t\t\t<sr7-slide id=\"SR7_20_1-64\" data-key=\"64\">\n\t\t\t\t\t\t<\/sr7-slide>\n\t\t\t\t\t<\/sr7-content>\n\t\t\t\t\t<image_lists style=\"display:none\">\n\t\t\t\t\t\t<img data-src=\"\/\/www.injex.de\/wp-content\/uploads\/2021\/03\/injex-about-start.jpg\" data-libid=\"55\" data-lib=\"medialibrary\" title=\"injex about start\" width=\"0\" height=\"0\" data-dbsrc=\"Ly93d3cuaW5qZXguZGUvd3AtY29udGVudC91cGxvYWRzLzIwMjEvMDMvaW5qZXgtYWJvdXQtc3RhcnQuanBn\"\/>\n\t\t\t\t\t<\/image_lists>\n\t\t\t\t<\/sr7-module>\n\t\t\t\t<script>\n\t\t\t\t\twindow.SR7 ??={};SR7.PMH ??={}; SR7.PMH[\"SR7_20_1\"] = {cn:100,state:false,fn: function() { if (window._tpt!==undefined && window._tpt.prepareModuleHeight !== undefined) {  _tpt.prepareModuleHeight({id:\"SR7_20_1\",el:[800,800,800,800,520],type:'standard',shdw:'0',gh:[800,800,800,800,520],gw:[1240,1240,1240,1240,480],vpt:['-200px&#039;,&#039;-200px&#039;,&#039;-200px&#039;,&#039;-200px&#039;,&#039;-200px'],size:{fullWidth:true, fullHeight:false},mh:'0',onh:0,onw:0,bg:{color:'{\"orig\":\"transparent\",\"type\":\"solid\",\"string\":\"transparent\"}'}});   SR7.PMH[\"SR7_20_1\"].state=true;} else if(SR7.PMH[\"SR7_20_1\"].cn-->0)\tsetTimeout( SR7.PMH[\"SR7_20_1\"].fn,19);}};SR7.PMH[\"SR7_20_1\" ].fn();\n\t\t\t\t<\/script>\n[\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; content_placement=&#8221;middle&#8221; css=&#8221;.vc_custom_1615497707051{padding-top: 85px !important;}&#8221;][vc_column][kalium_breadcrumb][vc_column_text css=&#8221;.vc_custom_1773744287494{margin-bottom: 0px !important;padding-bottom: 10px !important;}&#8221;]<\/p>\n<h2 class=\"header-text\"><strong>Certificates<\/strong><\/h2>\n<p>[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1773744424530{margin-top: 15px !important;}&#8221;]Quality is very important to us.<\/p>\n<p>We are certified according to ISO 13485: 2021 and for our own medical products (up to class II b) according to 93\/42 \/ EEC.<\/p>\n<p>The certifications show that the system described has been implemented effectively and that all required standard requirements are met.<\/p>\n<p>You will find our quality certificates and relevant information below:[\/vc_column_text][vc_separator color=&#8221;custom&#8221; accent_color=&#8221;#e8e8e8&#8243;][vc_row_inner content_placement=&#8221;bottom&#8221; css=&#8221;.vc_custom_1773742017277{padding-top: 45px !important;}&#8221;][vc_column_inner width=&#8221;1\/3&#8243;]\n<div id=\"interactive-banner-1-wrap-3472\" class=\"ult-banner-block ult-adjust-bottom-margin ult-bb-box  banner-style01 \"   style=\"\">\n\t<img decoding=\"async\" src=\"https:\/\/www.injex.de\/wp-content\/uploads\/2026\/03\/eg-cert-en-2026.png\" alt=\"null\">\n\t<h3  data-ultimate-target='#interactive-banner-1-wrap-3472 .bb-top-title '  data-responsive-json-new='{\"font-size\":\"\",\"line-height\":\"\"}'  class=\"title-center bb-top-title ult-responsive\" style=\"font-weight:normal;background:#ffffff;color:#000000;\">Annex II \u2013 excluding Section 4 of Council Directive 93\/42\/EEC concerning medical devices<\/h3>\n\t<div class=\"mask opaque-background\" style=\"background:#06a6ac;\">\n\t\t<div class=\"bb-back-icon\"><i class=\"Defaults-file-o\"  style= \"color:#ffffff;\"><\/i><\/div>\n\t\t<p class=\"\" style=\"font-weight:bold;color:#ffffff;\">Annex II \u2013 excluding Section 4 of Council Directive 93\/42\/EEC concerning medical devices<br \/>\n----- Injector, Ampule and Adapter according annex<\/p>\n\t<\/div><a class=\"bb-link\" href=\"https:\/\/www.injex.de\/wp-content\/uploads\/2021\/06\/IPG_InjektorAmpulleAdapter_En.pdf\" target=\"_blank\" rel=\"noopener\" ><\/a>\n<\/div>[\/vc_column_inner][vc_column_inner width=&#8221;1\/3&#8243;]\n<div id=\"interactive-banner-1-wrap-3191\" class=\"ult-banner-block ult-adjust-bottom-margin ult-bb-box  banner-style01 \"   style=\"\">\n\t<img decoding=\"async\" src=\"https:\/\/www.injex.de\/wp-content\/uploads\/2026\/03\/confirmation-letter-2026.png\" alt=\"null\">\n\t<h3  data-ultimate-target='#interactive-banner-1-wrap-3191 .bb-top-title '  data-responsive-json-new='{\"font-size\":\"\",\"line-height\":\"\"}'  class=\"title-center bb-top-title ult-responsive\" style=\"font-weight:normal;background:#ffffff;color:#000000;\">Notified Body Confirmation Letter<\/h3>\n\t<div class=\"mask opaque-background\" style=\"background:#06a6ac;\">\n\t\t<div class=\"bb-back-icon\"><i class=\"Defaults-file-o\"  style= \"color:#ffffff;\"><\/i><\/div>\n\t\t<p class=\"\" style=\"font-weight:bold;color:#ffffff;\">Confirmation of the status of a formal application, written agreement, and<br \/>\nappropriate surveillance in the framework of Regulation EU 2023\/607 amending<br \/>\nRegulations (EU) 2017\/745 and (EU) 2017\/746 as regards the transitional provisions<br \/>\nfor certain medical devices and in vitro diagnostic medical device<\/p>\n\t<\/div><a class=\"bb-link\" href=\"https:\/\/www.injex.de\/wp-content\/uploads\/2026\/03\/EC-Confirmation-Letter_DEU-DQS_20251124-20281231_IPG_EN.pdf\" target=\"_blank\" rel=\"noopener\" ><\/a>\n<\/div>[\/vc_column_inner][vc_column_inner width=&#8221;1\/3&#8243;]\n<div id=\"interactive-banner-1-wrap-3267\" class=\"ult-banner-block ult-adjust-bottom-margin ult-bb-box  banner-style01 \"   style=\"\">\n\t<img decoding=\"async\" src=\"https:\/\/www.injex.de\/wp-content\/uploads\/2026\/03\/cert-en-2026.png\" alt=\"null\">\n\t<h3  data-ultimate-target='#interactive-banner-1-wrap-3267 .bb-top-title '  data-responsive-json-new='{\"font-size\":\"\",\"line-height\":\"\"}'  class=\"title-center bb-top-title ult-responsive\" style=\"font-weight:normal;background:#ffffff;color:#000000;\">DIN EN ISO 13485 : 2021<\/h3>\n\t<div class=\"mask opaque-background\" style=\"background:#06a6ac;\">\n\t\t<div class=\"bb-back-icon\"><i class=\"Defaults-file-o\"  style= \"color:#ffffff;\"><\/i><\/div>\n\t\t<p class=\"\" style=\"font-weight:bold;color:#ffffff;\">DIN EN ISO 13485 : 2016 + Ber. 1 : 2017-07<br \/>\nScope:<br \/>\nDevelopment, Production and Distribution of needle free injection-systems, ampoules and<br \/>\nadapters.<\/p>\n\t<\/div><a class=\"bb-link\" href=\"https:\/\/www.injex.de\/wp-content\/uploads\/2026\/03\/ISO13485-Certificate_DEU-DQS_MP2021_20251220-20270409_IPG_EN.pdf\" target=\"_blank\" rel=\"noopener\" ><\/a>\n<\/div>[\/vc_column_inner][\/vc_row_inner][vc_row_inner css=&#8221;.vc_custom_1773741908797{padding-top: 45px !important;}&#8221; el_class=&#8221;u-justify-center&#8221;][vc_column_inner width=&#8221;1\/3&#8243;][vc_single_image image=&#8221;542&#8243; img_size=&#8221;medium&#8221; alignment=&#8221;center&#8221; onclick=&#8221;custom_link&#8221; img_link_target=&#8221;_blank&#8221; css=&#8221;&#8221; link=&#8221;https:\/\/www.dqs.de\/en\/kundendatenbank\/?tx_mydqs_customerdatabase%5Baction%5D=detail&amp;tx_mydqs_customerdatabase%5Bcontroller%5D=CustomerDatabase&amp;tx_mydqs_customerdatabase%5Bnumber%5D=544966&amp;cHash=53ae48c50899162fa4a3464069c67e44&#8243;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; content_placement=&#8221;middle&#8221; css=&#8221;.vc_custom_1615497707051{padding-top: 85px !important;}&#8221;][vc_column][kalium_breadcrumb][vc_column_text css=&#8221;.vc_custom_1773744287494{margin-bottom: 0px !important;padding-bottom: 10px !important;}&#8221;] Certificates [\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1773744424530{margin-top: 15px !important;}&#8221;]Quality is very important to us. We are certified according to ISO 13485: 2021 and for our own medical products (up to class II b) according to 93\/42 \/ EEC. The certifications show that the system described has been implemented&hellip;<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":358,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-448","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.injex.de\/en\/wp-json\/wp\/v2\/pages\/448","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.injex.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.injex.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.injex.de\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.injex.de\/en\/wp-json\/wp\/v2\/comments?post=448"}],"version-history":[{"count":14,"href":"https:\/\/www.injex.de\/en\/wp-json\/wp\/v2\/pages\/448\/revisions"}],"predecessor-version":[{"id":786,"href":"https:\/\/www.injex.de\/en\/wp-json\/wp\/v2\/pages\/448\/revisions\/786"}],"up":[{"embeddable":true,"href":"https:\/\/www.injex.de\/en\/wp-json\/wp\/v2\/pages\/358"}],"wp:attachment":[{"href":"https:\/\/www.injex.de\/en\/wp-json\/wp\/v2\/media?parent=448"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}