{"id":4214,"date":"2020-05-14T13:48:04","date_gmt":"2020-05-14T11:48:04","guid":{"rendered":"https:\/\/spilerdug.dk.web05.webtohosting.dk\/?page_id=4214"},"modified":"2026-08-17T14:11:57","modified_gmt":"2026-08-17T12:11:57","slug":"certificering-af-spiler","status":"publish","type":"page","link":"https:\/\/spilerdug.dk\/sv\/om-os\/certificering-og-maerkning\/certificering-af-spiler\/","title":{"rendered":"Certifiering av Spiler+"},"content":{"rendered":"<style>.kb-row-layout-id4214_ff7f2f-1e > .kt-row-column-wrap{align-content:start;}:where(.kb-row-layout-id4214_ff7f2f-1e > .kt-row-column-wrap) > .wp-block-kadence-column{justify-content:start;}.kb-row-layout-id4214_ff7f2f-1e > .kt-row-column-wrap{column-gap:var(--global-kb-gap-md, 2rem);row-gap:var(--global-kb-gap-md, 2rem);max-width:var( --global-content-width, 1400px );padding-left:var(--global-content-edge-padding);padding-right:var(--global-content-edge-padding);padding-top:var(--global-kb-spacing-3xl, 6.5rem);padding-bottom:var(--global-kb-spacing-3xl, 6.5rem);grid-template-columns:minmax(0, calc(35% - ((var(--global-kb-gap-md, 2rem) * 1 )\/2)))minmax(0, calc(65% - ((var(--global-kb-gap-md, 2rem) * 1 )\/2)));}.kb-row-layout-id4214_ff7f2f-1e > .kt-row-layout-overlay{opacity:0.30;}@media all and (max-width: 1024px){.kb-row-layout-id4214_ff7f2f-1e > .kt-row-column-wrap{padding-top:var(--global-kb-spacing-xxl, 5rem);padding-bottom:var(--global-kb-spacing-xxl, 5rem);grid-template-columns:repeat(2, minmax(0, 1fr));}}@media all and (max-width: 767px){.kb-row-layout-id4214_ff7f2f-1e > .kt-row-column-wrap{padding-top:var(--global-kb-spacing-lg, 3rem);padding-bottom:var(--global-kb-spacing-lg, 3rem);grid-template-columns:minmax(0, 1fr);}}<\/style><div class=\"kb-row-layout-wrap kb-row-layout-id4214_ff7f2f-1e alignnone wp-block-kadence-rowlayout\"><div class=\"kt-row-column-wrap kt-has-2-columns kt-row-layout-equal kt-tab-layout-inherit kt-mobile-layout-row kt-row-valign-top kb-theme-content-width\">\n<style>.kadence-column4214_2951a9-cd > .kt-inside-inner-col,.kadence-column4214_2951a9-cd > .kt-inside-inner-col:before{border-top-left-radius:0px;border-top-right-radius:0px;border-bottom-right-radius:0px;border-bottom-left-radius:0px;}.kadence-column4214_2951a9-cd > .kt-inside-inner-col{column-gap:var(--global-kb-gap-sm, 1rem);}.kadence-column4214_2951a9-cd > .kt-inside-inner-col{flex-direction:column;}.kadence-column4214_2951a9-cd > .kt-inside-inner-col > .aligncenter{width:100%;}.kadence-column4214_2951a9-cd > .kt-inside-inner-col:before{opacity:0.3;}.kadence-column4214_2951a9-cd{position:relative;}@media all and (max-width: 1024px){.kadence-column4214_2951a9-cd > .kt-inside-inner-col{flex-direction:column;justify-content:center;}}@media all and (max-width: 767px){.kadence-column4214_2951a9-cd > .kt-inside-inner-col{flex-direction:column;justify-content:center;}}<\/style>\n<div class=\"wp-block-kadence-column kadence-column4214_2951a9-cd kb-section-dir-vertical\"><div class=\"kt-inside-inner-col\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"220\" height=\"220\" src=\"https:\/\/spilerdug.dk\/wp-content\/uploads\/2016\/07\/ce_logo_220.jpg\" alt=\"\" class=\"wp-image-338\" title=\"\" srcset=\"https:\/\/spilerdug.dk\/wp-content\/uploads\/2016\/07\/ce_logo_220.jpg 220w, https:\/\/spilerdug.dk\/wp-content\/uploads\/2016\/07\/ce_logo_220-100x100.jpg 100w, https:\/\/spilerdug.dk\/wp-content\/uploads\/2016\/07\/ce_logo_220-150x150.jpg 150w\" sizes=\"auto, (max-width: 220px) 100vw, 220px\" \/><\/figure>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"88\" height=\"88\" src=\"https:\/\/spilerdug.dk\/wp-content\/uploads\/2020\/06\/gtin-stregkode.jpg\" alt=\"\" class=\"wp-image-4578\" style=\"width:143px;height:auto\" title=\"\"><\/figure>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n<\/div><\/div>\n\n\n<style>.kadence-column4214_13fe2b-bc > .kt-inside-inner-col,.kadence-column4214_13fe2b-bc > .kt-inside-inner-col:before{border-top-left-radius:0px;border-top-right-radius:0px;border-bottom-right-radius:0px;border-bottom-left-radius:0px;}.kadence-column4214_13fe2b-bc > .kt-inside-inner-col{column-gap:var(--global-kb-gap-sm, 1rem);}.kadence-column4214_13fe2b-bc > .kt-inside-inner-col{flex-direction:column;}.kadence-column4214_13fe2b-bc > .kt-inside-inner-col > .aligncenter{width:100%;}.kadence-column4214_13fe2b-bc > .kt-inside-inner-col:before{opacity:0.3;}.kadence-column4214_13fe2b-bc{position:relative;}@media all and (max-width: 1024px){.kadence-column4214_13fe2b-bc > .kt-inside-inner-col{flex-direction:column;justify-content:center;}}@media all and (max-width: 767px){.kadence-column4214_13fe2b-bc > .kt-inside-inner-col{flex-direction:column;justify-content:center;}}<\/style>\n<div class=\"wp-block-kadence-column kadence-column4214_13fe2b-bc\"><div class=\"kt-inside-inner-col\">\n<p class=\"wp-block-paragraph\">Vores Spiler+ vendesystem er CE-m\u00e6rket i overensstemmelse med Europa-Parlamentets og R\u00e5dets forordning (EU) MDR 2017\/745 af 5. april 2017 om medicinsk udstyr.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">I f\u00f6rbindelse med CE-m\u00e4rkning av Spiler+ v\u00e4ndsystem har man utarbetat en \u00f6verensst\u00e4mmelserapport och f\u00f6rs\u00e4kran om \u00f6verensst\u00e4mmelse.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">En riskbed\u00f6mning har utarbetats och ligger till grund f\u00f6r den generella v\u00e4gledningen i anv\u00e4ndning av Spiler+ v\u00e4ndsystem. Ut\u00f6ver det har vi som en del av v\u00e5r kliniska \u00f6vervakning och utv\u00e4rdering st\u00e4ndig uppf\u00f6ljning via den n\u00e4ra kontakten vi har med kunderna.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Det betyder f\u00f6r er, att v\u00e5rt Spiler+ v\u00e4ndsystem<\/strong><strong>:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Anm\u00e4ld till l\u00e4kemedelsmyndigheten<\/li>\n\n\n\n<li>Bevakad via klinisk evaluering<\/li>\n\n\n\n<li>Riskbed\u00f6md<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">N\u00e4r Spiler+ v\u00e4ndsystem levereras medf\u00f6ljer dessutom en leverant\u00f6rsv\u00e4gledning med alla relevanta punkter.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>M\u00e4rkning och sp\u00e5rning av Spiler+ v\u00e4ndsystem<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Den senaste f\u00f6rordningen f\u00f6r medicinska produkter (EU 2017\/745) st\u00e4ller ytterligare krav till m\u00e4rkning och sp\u00e5rbarhet av medicinska produkter. Hos Spilerdug ApS registrera vi v\u00e5ra varor enligt rekommenderad GTIN standard. P\u00e5 det s\u00e4ttet kan vi koppla den minsta leveransenheten med leveransadressen hos kunden genom en standardiserad streckkod, s\u00e5 att vi alltid kan sp\u00e5ra produkten tillbaka till den faktiska produktionen.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Spiler+ er testet for mere end 300 skadelige stoffer, hvilket ligger langt ud over lovgivningen i EU, og sikrer mod skadelig kemi i produktionen.<\/p>\n<\/div><\/div>\n\n<\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>Vores Spiler+ vendesystem er CE-m\u00e6rket i overensstemmelse med Europa-Parlamentets og R\u00e5dets forordning (EU) MDR 2017\/745 af 5. april 2017 om medicinsk udstyr. I forbindelse med CE-m\u00e6rkning af Spiler+ vendesystem er der udarbejdet overensstemmelsesrapport og overensstemmelseserkl\u00e6ringer. Der er udarbejdet en risikovurdering som grundlag for den generelle vejledning i brugen af Spiler+ vendesystem. Derudover f\u00f8lger vi l\u00f8bende&#8230;<\/p>","protected":false},"author":24,"featured_media":0,"parent":3599,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","_kad_post_transparent":"","_kad_post_title":"","_kad_post_layout":"","_kad_post_sidebar_id":"","_kad_post_content_style":"","_kad_post_vertical_padding":"","_kad_post_feature":"","_kad_post_feature_position":"","_kad_post_header":false,"_kad_post_footer":false,"_kad_post_classname":"","footnotes":""},"class_list":["post-4214","page","type-page","status-publish","hentry"],"acf":[],"taxonomy_info":[],"featured_image_src_large":false,"author_info":{"display_name":"Nanna Westby","author_link":"https:\/\/spilerdug.dk\/sv\/author\/nanna\/"},"comment_info":0,"_links":{"self":[{"href":"https:\/\/spilerdug.dk\/sv\/wp-json\/wp\/v2\/pages\/4214","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/spilerdug.dk\/sv\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/spilerdug.dk\/sv\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/spilerdug.dk\/sv\/wp-json\/wp\/v2\/users\/24"}],"replies":[{"embeddable":true,"href":"https:\/\/spilerdug.dk\/sv\/wp-json\/wp\/v2\/comments?post=4214"}],"version-history":[{"count":23,"href":"https:\/\/spilerdug.dk\/sv\/wp-json\/wp\/v2\/pages\/4214\/revisions"}],"predecessor-version":[{"id":13128,"href":"https:\/\/spilerdug.dk\/sv\/wp-json\/wp\/v2\/pages\/4214\/revisions\/13128"}],"up":[{"embeddable":true,"href":"https:\/\/spilerdug.dk\/sv\/wp-json\/wp\/v2\/pages\/3599"}],"wp:attachment":[{"href":"https:\/\/spilerdug.dk\/sv\/wp-json\/wp\/v2\/media?parent=4214"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}