{"id":9832,"date":"2025-01-24T08:30:25","date_gmt":"2025-01-24T06:30:25","guid":{"rendered":"https:\/\/uat.safelaser.hu\/medical-device-certification\/"},"modified":"2025-07-16T17:24:27","modified_gmt":"2025-07-16T17:24:27","slug":"medical-device-certification","status":"publish","type":"page","link":"https:\/\/safelaser.hu\/en\/medical-device-certification\/","title":{"rendered":"Medical Device Certification"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"9832\" class=\"elementor elementor-9832 elementor-83\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-21da590 e-flex e-con-boxed e-con e-parent\" data-id=\"21da590\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-0a63bf7 e-grid e-con-full e-con e-child\" data-id=\"0a63bf7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-e858638 e-con-full e-flex e-con e-child\" data-id=\"e858638\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fdc3c61 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"fdc3c61\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_mobile&quot;:&quot;none&quot;,&quot;_animation_delay&quot;:100}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Our medical soft lasers are classified as Class IIa medical devices <strong>in accordance with Hungarian Regulation 4\/2009. (III.17.) <\/strong>of the Ministry of Health (E\u00fcM).<\/p><p>Our company operates a quality management system compliant with the MSZ EN ISO 13485:2016 standard and the quality requirements set forth in the Hungarian Regulation 4\/2009. (III.17.) E\u00fcM.  <\/p><p>This standard defines the quality requirements for the following processes related to medical devices:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-fc3fc53 e-grid e-con-full e-con e-child\" data-id=\"fc3fc53\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-23c2587 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-invisible elementor-widget elementor-widget-icon-list\" data-id=\"23c2587\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_mobile&quot;:&quot;none&quot;,&quot;_animation_delay&quot;:200}\" data-widget_type=\"icon-list.default\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"Layer_1\" x=\"0px\" y=\"0px\" viewBox=\"0 0 25 24\" style=\"enable-background:new 0 0 25 24;\" xml:space=\"preserve\"><g>\t<path d=\"M9.7,10.3c-0.3-0.3-0.9-0.3-1.2,0c-0.3,0.3-0.3,0.9,0,1.2l3.3,3.3c0.2,0.2,0.4,0.2,0.6,0.2c0.2,0,0.4-0.1,0.6-0.2L24.3,3.7  c0.3-0.3,0.3-0.9,0-1.2c-0.3-0.3-0.9-0.3-1.2,0L12.5,13.1L9.7,10.3z\"><\/path>\t<path d=\"M23.7,10.1c-0.5,0-0.8,0.4-0.8,0.8v1c0,2.2-0.7,4.4-2.1,6.2c-1.3,1.8-3.2,3.1-5.3,3.7c-2.1,0.6-4.4,0.5-6.5-0.2  c-2.1-0.8-3.9-2.2-5.1-4.1c-1.2-1.9-1.8-4.1-1.6-6.3c0.1-2.2,1-4.3,2.5-6c1.4-1.7,3.4-2.9,5.6-3.4c2.2-0.5,4.5-0.3,6.5,0.6  c0.4,0.2,0.9,0,1.1-0.4c0.2-0.4,0-0.9-0.4-1.1c-2.3-1-5-1.3-7.5-0.7C7.3,0.9,5,2.2,3.4,4.2c-1.7,2-2.7,4.4-2.9,7  c-0.2,2.6,0.5,5.2,1.9,7.3c1.4,2.2,3.5,3.8,5.9,4.7c1.3,0.5,2.7,0.7,4.2,0.7c1.1,0,2.3-0.2,3.4-0.5c2.5-0.7,4.7-2.3,6.2-4.3  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d=\"M9.7,10.3c-0.3-0.3-0.9-0.3-1.2,0c-0.3,0.3-0.3,0.9,0,1.2l3.3,3.3c0.2,0.2,0.4,0.2,0.6,0.2c0.2,0,0.4-0.1,0.6-0.2L24.3,3.7  c0.3-0.3,0.3-0.9,0-1.2c-0.3-0.3-0.9-0.3-1.2,0L12.5,13.1L9.7,10.3z\"><\/path>\t<path d=\"M23.7,10.1c-0.5,0-0.8,0.4-0.8,0.8v1c0,2.2-0.7,4.4-2.1,6.2c-1.3,1.8-3.2,3.1-5.3,3.7c-2.1,0.6-4.4,0.5-6.5-0.2  c-2.1-0.8-3.9-2.2-5.1-4.1c-1.2-1.9-1.8-4.1-1.6-6.3c0.1-2.2,1-4.3,2.5-6c1.4-1.7,3.4-2.9,5.6-3.4c2.2-0.5,4.5-0.3,6.5,0.6  c0.4,0.2,0.9,0,1.1-0.4c0.2-0.4,0-0.9-0.4-1.1c-2.3-1-5-1.3-7.5-0.7C7.3,0.9,5,2.2,3.4,4.2c-1.7,2-2.7,4.4-2.9,7  c-0.2,2.6,0.5,5.2,1.9,7.3c1.4,2.2,3.5,3.8,5.9,4.7c1.3,0.5,2.7,0.7,4.2,0.7c1.1,0,2.3-0.2,3.4-0.5c2.5-0.7,4.7-2.3,6.2-4.3  c1.5-2.1,2.4-4.6,2.4-7.2v-1C24.5,10.5,24.1,10.1,23.7,10.1z\"><\/path><\/g><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Manufacturing<br><br><\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-885068a elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-invisible elementor-widget elementor-widget-icon-list\" data-id=\"885068a\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_mobile&quot;:&quot;none&quot;,&quot;_animation_delay&quot;:200}\" data-widget_type=\"icon-list.default\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"Layer_1\" x=\"0px\" y=\"0px\" viewBox=\"0 0 25 24\" style=\"enable-background:new 0 0 25 24;\" xml:space=\"preserve\"><g>\t<path d=\"M9.7,10.3c-0.3-0.3-0.9-0.3-1.2,0c-0.3,0.3-0.3,0.9,0,1.2l3.3,3.3c0.2,0.2,0.4,0.2,0.6,0.2c0.2,0,0.4-0.1,0.6-0.2L24.3,3.7  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id=\"Layer_1\" x=\"0px\" y=\"0px\" viewBox=\"0 0 25 24\" style=\"enable-background:new 0 0 25 24;\" xml:space=\"preserve\"><g>\t<path d=\"M9.7,10.3c-0.3-0.3-0.9-0.3-1.2,0c-0.3,0.3-0.3,0.9,0,1.2l3.3,3.3c0.2,0.2,0.4,0.2,0.6,0.2c0.2,0,0.4-0.1,0.6-0.2L24.3,3.7  c0.3-0.3,0.3-0.9,0-1.2c-0.3-0.3-0.9-0.3-1.2,0L12.5,13.1L9.7,10.3z\"><\/path>\t<path d=\"M23.7,10.1c-0.5,0-0.8,0.4-0.8,0.8v1c0,2.2-0.7,4.4-2.1,6.2c-1.3,1.8-3.2,3.1-5.3,3.7c-2.1,0.6-4.4,0.5-6.5-0.2  c-2.1-0.8-3.9-2.2-5.1-4.1c-1.2-1.9-1.8-4.1-1.6-6.3c0.1-2.2,1-4.3,2.5-6c1.4-1.7,3.4-2.9,5.6-3.4c2.2-0.5,4.5-0.3,6.5,0.6  c0.4,0.2,0.9,0,1.1-0.4c0.2-0.4,0-0.9-0.4-1.1c-2.3-1-5-1.3-7.5-0.7C7.3,0.9,5,2.2,3.4,4.2c-1.7,2-2.7,4.4-2.9,7  c-0.2,2.6,0.5,5.2,1.9,7.3c1.4,2.2,3.5,3.8,5.9,4.7c1.3,0.5,2.7,0.7,4.2,0.7c1.1,0,2.3-0.2,3.4-0.5c2.5-0.7,4.7-2.3,6.2-4.3  c1.5-2.1,2.4-4.6,2.4-7.2v-1C24.5,10.5,24.1,10.1,23.7,10.1z\"><\/path><\/g><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Sales<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2195c95 e-grid e-con-boxed e-con e-parent\" data-id=\"2195c95\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-3226462 e-con-full e-flex e-con e-child\" data-id=\"3226462\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b25cf5c animated-slow elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"b25cf5c\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;,&quot;_animation_mobile&quot;:&quot;none&quot;,&quot;_animation_delay&quot;:500}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>The certification ensures that the user receives a safe, effective device of controlled quality, supported by professional servicing.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c379edf animated-slow elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"c379edf\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;,&quot;_animation_mobile&quot;:&quot;none&quot;,&quot;_animation_delay&quot;:500}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Only CE-marked medical devices may be placed on the market in the European Union.<\/p><p>EC Certificate Number: 144783-18-09-05<\/p><p>Quality Management System Certificate Number: 145223-24-07-08<\/p><p>Notified Body: CE Certiso CE Certiso Orvos- \u00e9s K\u00f3rh\u00e1ztechnikai Ellen\u0151rz\u0151 \u00e9s Tan\u00fas\u00edt\u00f3 Kft. (NB 2409) <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-04cfb2c elementor-skin-slideshow elementor-arrows-yes elementor-invisible elementor-widget elementor-widget-media-carousel\" data-id=\"04cfb2c\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;skin&quot;:&quot;slideshow&quot;,&quot;autoplay_speed&quot;:10000,&quot;space_between&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:12,&quot;sizes&quot;:[]},&quot;_animation&quot;:&quot;fadeInRight&quot;,&quot;effect&quot;:&quot;slide&quot;,&quot;show_arrows&quot;:&quot;yes&quot;,&quot;speed&quot;:500,&quot;autoplay&quot;:&quot;yes&quot;,&quot;loop&quot;:&quot;yes&quot;,&quot;pause_on_interaction&quot;:&quot;yes&quot;,&quot;space_between_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&quot;:[]},&quot;space_between_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&quot;:[]}}\" data-widget_type=\"media-carousel.default\">\n\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-main-swiper swiper\" role=\"region\" aria-roledescription=\"carousel\" aria-label=\"Slides\">\n\t\t\t\t<div class=\"swiper-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-carousel-image\" role=\"img\" aria-label=\"cert4\" style=\"background-image: url(&#039;https:\/\/safelaser.hu\/wp-content\/uploads\/2025\/02\/cert4.png&#039;)\">\n\n\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-carousel-image\" role=\"img\" aria-label=\"DO NOT COPY\" style=\"background-image: url(&#039;https:\/\/safelaser.hu\/wp-content\/uploads\/2025\/07\/DO-NOT-COPY-2.png&#039;)\">\n\n\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-carousel-image\" role=\"img\" aria-label=\"cert1\" style=\"background-image: url(&#039;https:\/\/safelaser.hu\/wp-content\/uploads\/2025\/02\/cert1.png&#039;)\">\n\n\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-carousel-image\" role=\"img\" aria-label=\"cert2\" style=\"background-image: url(&#039;https:\/\/safelaser.hu\/wp-content\/uploads\/2025\/02\/cert2.png&#039;)\">\n\n\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-carousel-image\" role=\"img\" aria-label=\"cert3\" style=\"background-image: 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url(&#039;https:\/\/safelaser.hu\/wp-content\/uploads\/2025\/02\/cert4.png&#039;)\">\n\n\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-carousel-image\" role=\"img\" aria-label=\"DO NOT COPY\" style=\"background-image: url(&#039;https:\/\/safelaser.hu\/wp-content\/uploads\/2025\/07\/DO-NOT-COPY-2.png&#039;)\">\n\n\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-carousel-image\" role=\"img\" aria-label=\"cert1\" style=\"background-image: url(&#039;https:\/\/safelaser.hu\/wp-content\/uploads\/2025\/02\/cert1.png&#039;)\">\n\n\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-carousel-image\" role=\"img\" aria-label=\"cert2\" style=\"background-image: url(&#039;https:\/\/safelaser.hu\/wp-content\/uploads\/2025\/02\/cert2.png&#039;)\">\n\n\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" role=\"group\" aria-roledescription=\"slide\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-carousel-image\" role=\"img\" aria-label=\"cert3\" style=\"background-image: url(&#039;https:\/\/safelaser.hu\/wp-content\/uploads\/2025\/02\/cert3.png&#039;)\">\n\n\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Our medical soft lasers are classified as Class IIa medical devices in accordance with Hungarian Regulation 4\/2009. (III.17.) of the Ministry of Health (E\u00fcM). Our company operates a quality management system compliant with the MSZ EN ISO 13485:2016 standard and the quality requirements set forth in the Hungarian Regulation 4\/2009. (III.17.) E\u00fcM. This standard defines [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-9832","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/safelaser.hu\/en\/wp-json\/wp\/v2\/pages\/9832","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/safelaser.hu\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/safelaser.hu\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/safelaser.hu\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/safelaser.hu\/en\/wp-json\/wp\/v2\/comments?post=9832"}],"version-history":[{"count":2,"href":"https:\/\/safelaser.hu\/en\/wp-json\/wp\/v2\/pages\/9832\/revisions"}],"predecessor-version":[{"id":24644,"href":"https:\/\/safelaser.hu\/en\/wp-json\/wp\/v2\/pages\/9832\/revisions\/24644"}],"wp:attachment":[{"href":"https:\/\/safelaser.hu\/en\/wp-json\/wp\/v2\/media?parent=9832"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}