{"id":34453,"date":"2025-07-10T12:25:54","date_gmt":"2025-07-10T10:25:54","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=34453"},"modified":"2025-07-11T12:20:41","modified_gmt":"2025-07-11T10:20:41","slug":"que-es-y-para-que-sirve-la-udi-para-productos-sanitarios-y-de-diagnostico-in-vitro","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2025\/07\/10\/que-es-y-para-que-sirve-la-udi-para-productos-sanitarios-y-de-diagnostico-in-vitro\/","title":{"rendered":"\u00bfQu\u00e9 es y para qu\u00e9 sirve la UDI para productos sanitarios y de diagn\u00f3stico in vitro?"},"content":{"rendered":"<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:1144px;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:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p><strong>La Identificaci\u00f3n \u00danica de Productos (UDI)<\/strong> es un sistema de identificaci\u00f3n mundial cuyo objetivo es mejorar la <strong>trazabilidad <\/strong>y la <strong>seguridad<\/strong> de los productos sanitarios y los productos sanitarios para diagn\u00f3stico in vitro. El UDI consiste en una serie de c\u00f3digos alfanum\u00e9ricos que permiten la identificaci\u00f3n \u00fanica de cada producto, para facilitar el seguimiento a lo largo de la cadena de suministro.<\/p>\n<p>El c\u00f3digo UDI consta de dos partes diferenciadas:<\/p>\n<ul>\n<li><strong>UDI-DI (Identificador de dispositivo)<\/strong><\/li>\n<\/ul>\n<p>El <strong>UDI-DI<\/strong> es el identificador \u00fanico asignado a un <strong>modelo de dispositivo espec\u00edfico<\/strong>.<\/p>\n<p>Este identificador permanece <strong>invariable para todos los dispositivos<\/strong> que comparten el mismo modelo, configuraci\u00f3n y uso previsto. Cualquier cambio significativo en el producto, como un cambio de tama\u00f1o, tipo o embalaje, requiere la asignaci\u00f3n de un nuevo UDI-DI.<\/p>\n<ul>\n<li><strong>UDI-PI (Identificador de producci\u00f3n)<\/strong><\/li>\n<\/ul>\n<p>El <strong>UDI-PI<\/strong> es el identificador de la <strong>unidad de producci\u00f3n individual<\/strong> de un producto.<\/p>\n<p>Incluye, en su caso, los siguientes elementos:<\/p>\n<ul>\n<li>Lote o n\u00famero de serie<\/li>\n<li>Identificador de software (si aplicable)<\/li>\n<li>Fecha de fabricaci\u00f3n<\/li>\n<li>Fecha de caducidad<\/li>\n<\/ul>\n<p>El UDI-PI <strong>var\u00eda <\/strong>para cada pieza individual y para cada lote de producci\u00f3n.<\/p>\n<h2>Principales caracter\u00edsticas del UDI<\/h2>\n<ul>\n<li><strong>Doble formato<\/strong>: el UDI aparece en la etiqueta del dispositivo en formato legible por el ser humano o en formato AIDC (Automatic Identification and Data Capture), por ejemplo, un c\u00f3digo de barras lineal o un c\u00f3digo 2D (por ejemplo, un Data Matrix).<\/li>\n<li><strong>Escaneabilidad<\/strong>: est\u00e1 dise\u00f1ado para ser le\u00eddo y escaneado f\u00e1cilmente por profesionales sanitarios, distribuidores y autoridades reguladoras.<\/li>\n<li><strong>Registro en<\/strong> <strong>EUDAMED<\/strong>: el UDI-DI debe registrarse en la base de datos europea EUDAMED. Este registro asocia el UDI-DI con informaci\u00f3n clave sobre el dispositivo.<\/li>\n<\/ul>\n<\/div><div class=\"fusion-image-element \" style=\"--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\"><img decoding=\"async\" width=\"1920\" height=\"1080\" title=\"codiceES\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/07\/codiceES.png\" alt class=\"img-responsive wp-image-34455\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/07\/codiceES-200x113.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/07\/codiceES-400x225.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/07\/codiceES-600x338.png 600w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/07\/codiceES-800x450.png 800w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/07\/codiceES-1200x675.png 1200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/07\/codiceES.png 1920w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 1200px\" \/><\/span><\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[891,1911],"tags":[1949,1948,1682,1645,1947,1950,1953,1951,1952],"class_list":["post-34453","post","type-post","status-publish","format-standard","hentry","category-faq-es","category-udi-en-productos-sanitarios","tag-dispositivos-de-diagnostico-in-vitro","tag-identificacion-de-productos-sanitarios","tag-ivd-es-2","tag-productos-sanitarios-es","tag-trazabilidad-de-productos-sanitarios","tag-udi-es-2","tag-udi-ivd-es","tag-udi-di-es","tag-udi-pi-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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