{"id":5514,"date":"2021-03-19T10:23:28","date_gmt":"2021-03-19T10:23:28","guid":{"rendered":"https:\/\/www.grafokett.se\/?p=5514"},"modified":"2026-11-02T14:09:00","modified_gmt":"2026-11-02T14:09:00","slug":"what-is-basic-udi","status":"publish","type":"post","link":"https:\/\/www.grafokett.se\/en\/what-is-basic-udi\/","title":{"rendered":"What is Basic UDI?"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1352px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-1 fusion-sep-none fusion-title-text fusion-title-size-one\"><h1 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:65;line-height:1.1;\">What is Basic UDI?<\/h1><\/div><div class=\"fusion-text fusion-text-1\"><p id=\"tw-target-text\" class=\"tw-data-text tw-text-large XcVN5d tw-ta\" dir=\"ltr\" data-placeholder=\"\u00d6vers\u00e4ttning\"><span lang=\"en\">A registration number that identifies a group of medical devices with the same purpose, risk class and comparable design and manufacturing functions. In general, a Basic UDI-DI consists of four elements: <\/span><\/p>\n<ul>\n<li class=\"tw-data-text tw-text-large XcVN5d tw-ta\" dir=\"ltr\" data-placeholder=\"\u00d6vers\u00e4ttning\"><span lang=\"en\">A specific start for an issuing body (eg GS1 codes start with &#8220;01&#8221;) <\/span><\/li>\n<li class=\"tw-data-text tw-text-large XcVN5d tw-ta\" dir=\"ltr\" data-placeholder=\"\u00d6vers\u00e4ttning\"><span lang=\"en\">Manufacturer code <\/span><\/li>\n<li class=\"tw-data-text tw-text-large XcVN5d tw-ta\" dir=\"ltr\" data-placeholder=\"\u00d6vers\u00e4ttning\"><span lang=\"en\">Product group code <\/span><\/li>\n<li class=\"tw-data-text tw-text-large XcVN5d tw-ta\" dir=\"ltr\" data-placeholder=\"\u00d6vers\u00e4ttning\"><span lang=\"en\">Check digit <\/span><\/li>\n<\/ul>\n<p><span lang=\"en\">Basic UDI-DI is used to register the units in EUDAMED and must be referred to in relevant documents (ie in the certificates and technical documentation including operating instructions). However, it must not be stated either on the product packaging or on the product itself. The manufacturers of medical devices are responsible for maintaining a mapping between the Basic UDI-DI and all associated (underlying) UDI-DIs. <\/span><\/p>\n<\/div><div class=\"fusion-video fusion-youtube\" style=\"--awb-max-width:600px;--awb-max-height:360px;--awb-align-self:center;--awb-width:100%;\"><div class=\"video-shortcode\"><div class=\"fluid-width-video-wrapper\" style=\"padding-top:60%;\" ><iframe title=\"YouTube video player 1\" src=\"https:\/\/www.youtube.com\/embed\/vjvjJdcSWbg?wmode=transparent&autoplay=0\" width=\"600\" height=\"360\" allowfullscreen allow=\"autoplay; fullscreen\"><\/iframe><\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-margin-top:50px;--awb-background-color:#efefef;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1352px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-2 fusion-sep-none fusion-title-text fusion-title-size-two\"><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:55;line-height:1.1;\">What is Basic UDI and Unique Device Identification?<\/h2><\/div><div class=\"fusion-text fusion-text-2\" style=\"--awb-text-transform:none;\"><p>Basic UDI (Unique Device Identification) is a system introduced by the European Union&#8217;s Medical Device Regulation (MDR) 2017. It requires medical device manufacturers to assign unique identifiers to their products. The primary purpose is to improve traceability and enhance patient safety.<\/p>\n<p class=\"p1\">The MDR 2017 defines UDI as &#8220;a unique identifier assigned to a device, consisting of a device identifier (DI) and a production identifier (PI).&#8221; These two components provide different types of information.<\/p>\n<p class=\"p1\">The DI is a globally unique code that identifies a specific device model and its intended use. In contrast, the PI contains production-related information. This may include the production date, manufacturer&#8217;s identifier, and batch number.<\/p>\n<p class=\"p1\">Together, these identifiers make it possible to trace a medical device throughout its entire life cycle.<\/p>\n<\/div><div class=\"fusion-title title fusion-title-3 fusion-sep-none fusion-title-text fusion-title-size-two\"><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:55;line-height:1.1;\"><p class=\"p1\">How UDI improves traceability and patient safety<\/p><\/h2><\/div><div class=\"fusion-text fusion-text-3\" style=\"--awb-text-transform:none;\"><p>One important benefit of UDI is improved access to device information. In the event of an adverse event, incident, or product recall, health authorities and healthcare providers can quickly retrieve relevant data.<\/p>\n<p class=\"p1\">For example, this information may include the device&#8217;s history, usage, and previous adverse events. As a result, potential issues can be investigated and resolved more efficiently.<\/p>\n<p class=\"p1\">UDI can also support more efficient inventory management. Healthcare providers can more easily keep track of the medical devices they use. This may help reduce unnecessary purchases of duplicate or expired devices.<\/p>\n<p class=\"p1\">To comply with the MDR 2017, manufacturers must follow the EU UDI requirements. They must include the UDI on the device label and in the accompanying documentation. In addition, relevant UDI information must be entered into EUDAMED.<\/p>\n<p class=\"p1\">Overall, UDI improves the identification and traceability of medical devices. It also makes relevant information easier to access when incidents or product recalls occur.<\/p>\n<\/div><div class=\"fusion-text fusion-text-4\" style=\"--awb-text-transform:none;\"><p>Read all about it here <a href=\"https:\/\/health.ec.europa.eu\/medical-devices-topics-interest\/unique-device-identifier-udi_en\">UDI &#8211; Unique Device Identifier<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-3 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-bottom:50px;--awb-margin-top:50px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1352px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-padding-top:50px;--awb-padding-bottom:0px;--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:3.84%;--awb-width-medium:50%;--awb-order-medium:0;--awb-spacing-right-medium:3.84%;--awb-spacing-left-medium:3.84%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-4 fusion-sep-none fusion-title-center fusion-title-text fusion-title-size-two\" style=\"--awb-font-size:45px;\"><h2 class=\"fusion-title-heading title-heading-center fusion-responsive-typography-calculated\" style=\"margin:0;font-size:1em;--fontSize:45;line-height:1.1;\">Say hello to better label management<\/h2><\/div><div class=\"fusion-text fusion-text-5\" style=\"--awb-text-transform:none;\"><p style=\"text-align: center;\"><span lang=\"EN-US\">Cloudlabel is a label management software.\u00a0<\/span><span lang=\"EN-GB\">The software makes it easy to generate barcodes as well as design, manage and print labels. Anywhere in the world.<\/span><\/p>\n<\/div><ul style=\"--awb-size:16px;--awb-line-height:27.2px;--awb-icon-width:27.2px;--awb-icon-height:27.2px;--awb-icon-margin:11.2px;--awb-content-margin:38.4px;--awb-circlecolor:#f5910a;--awb-circle-yes-font-size:14.08px;\" class=\"fusion-checklist fusion-checklist-1 fusion-checklist-default type-icons\"><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon awb-icon-check\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Document approval workflow built-in<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon awb-icon-check\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Verify label-design with business data before approval<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon awb-icon-check\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p>Only approved labels are used in production<\/p>\n<\/div><\/li><\/ul><div style=\"text-align:left;\"><a class=\"fusion-button button-flat fusion-button-default-size button-custom fusion-button-default button-1 fusion-button-default-span \" style=\"--button_accent_color:#ffffff;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button-border-radius-top-left:4px;--button-border-radius-top-right:4px;--button-border-radius-bottom-right:4px;--button-border-radius-bottom-left:4px;--button_gradient_top_color:#2a4363;--button_gradient_bottom_color:#2a4363;--button_gradient_top_color_hover:#f59100;--button_gradient_bottom_color_hover:#f59100;--button_margin-top:25px;\" target=\"_self\" href=\"https:\/\/grafokettonline.com\/#\/register\" id=\"get-started-btn-bottom\"><span class=\"fusion-button-text\">Get started for free<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-3 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:3.84%;--awb-width-medium:50%;--awb-order-medium:0;--awb-spacing-right-medium:3.84%;--awb-spacing-left-medium:3.84%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-image-element \" style=\"--awb-margin-top:50px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\" style=\"border-radius:20px;\"><img decoding=\"async\" width=\"2048\" height=\"1377\" alt=\"Label preview in cloudlabel.com\" title=\"Screenshot 2023-02-01 at 13.17.03\" src=\"https:\/\/www.grafokett.se\/wp-content\/uploads\/2023\/02\/Screenshot-2023-02-01-at-13.17.03.png?_t=1683030740\" class=\"img-responsive wp-image-7142\" srcset=\"https:\/\/www.grafokett.se\/wp-content\/uploads\/2023\/02\/Screenshot-2023-02-01-at-13.17.03-200x135.png 200w, https:\/\/www.grafokett.se\/wp-content\/uploads\/2023\/02\/Screenshot-2023-02-01-at-13.17.03-400x269.png 400w, https:\/\/www.grafokett.se\/wp-content\/uploads\/2023\/02\/Screenshot-2023-02-01-at-13.17.03-600x404.png 600w, https:\/\/www.grafokett.se\/wp-content\/uploads\/2023\/02\/Screenshot-2023-02-01-at-13.17.03-800x538.png 800w, https:\/\/www.grafokett.se\/wp-content\/uploads\/2023\/02\/Screenshot-2023-02-01-at-13.17.03-1200x807.png 1200w, https:\/\/www.grafokett.se\/wp-content\/uploads\/2023\/02\/Screenshot-2023-02-01-at-13.17.03.png 2048w\" sizes=\"(max-width: 640px) 100vw, 800px\" \/><\/span><\/div><div class=\"fusion-text fusion-text-6 bottom-cta\" style=\"--awb-content-alignment:left;--awb-text-transform:none;--awb-margin-top:25px;\"><p>or <a id=\"book-demo-txt-button-bottom\" href=\"https:\/\/www.grafokett.se\/en\/cloud-label-pricing\/#book-demo\">book a demo with our sales team<\/a><\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-4 fusion_builder_column_1_2 1_2 fusion-flex-column fusion-flex-align-self-center bottom-cta\" style=\"--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:3.84%;--awb-width-medium:50%;--awb-order-medium:0;--awb-spacing-right-medium:3.84%;--awb-spacing-left-medium:3.84%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-5 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-padding-top:10px;--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:3.84%;--awb-width-medium:50%;--awb-order-medium:0;--awb-spacing-right-medium:3.84%;--awb-spacing-left-medium:3.84%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-space-around fusion-content-layout-column\"><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":5,"featured_media":5070,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[184,160,155,40],"tags":[],"class_list":["post-5514","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-archives","category-display-en","category-displayen","category-start-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.8 (Yoast SEO v28.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>What is Basic UDI? - Grafokett AB<\/title>\n<meta name=\"description\" content=\"What is Basic 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