
{"id":10855,"date":"2026-05-15T11:53:16","date_gmt":"2026-05-15T11:53:16","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/?page_id=10855"},"modified":"2026-06-03T09:17:30","modified_gmt":"2026-06-03T09:17:30","slug":"eudamed-bulk-xml-udi-device-registration-support","status":"publish","type":"page","link":"https:\/\/www.kalitekit.com.tr\/en\/eudamed-bulk-xml-udi-device-registration-support\/","title":{"rendered":"EUDAMED Bulk XML &amp; UDI Device Registration Support"},"content":{"rendered":"<p class=\"wp-block-paragraph\">EUDAMED bulk XML preparation is a critical step for medical device manufacturers, authorised representatives and exporters who need to organise device registration data in a structured and compliant format. Preparing UDI-DI, Basic UDI-DI, EMDN code, risk class, device model, catalogue reference and manufacturer information correctly helps reduce registration errors and supports a smoother EUDAMED device registration process.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.kalitekit.com.tr\/en\/eudamed-toplu-urun-kaydi-ve-xml-hazirlama-hizmeti\/\">KaliteKit provides EUDAMED bulk XML<\/a> and UDI device registration support for companies managing multiple medical devices, product variants or large device portfolios. The service focuses on data review, Excel template preparation, missing field identification, consistency checks and XML-ready device registration data structuring.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For companies with many UDI-DI records, manual data preparation can create a high risk of duplication, missing information or inconsistent device grouping. A structured EUDAMED bulk XML approach helps manufacturers organise their device data more efficiently before submission.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">KaliteKit supports the preparation and review of key EUDAMED data elements including Basic UDI-DI, UDI-DI, <a href=\"https:\/\/www.kalitekit.com.tr\/en\/emdn-kod-arama-kiti\/\">EMDN code<\/a>, device trade name, model, catalogue reference, risk class, regulatory status, packaging information and internal product notes. This support is especially useful for companies preparing bulk registrations or validating their data before upload.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">If your company needs support for EUDAMED bulk XML preparation, UDI device registration data review or Excel-to-XML structuring, KaliteKit can help you prepare a more consistent and controlled registration dataset. <a href=\"https:\/\/health.ec.europa.eu\/medical-devices-eudamed_en\" target=\"_blank\" rel=\"noopener\">For official information about EUDAMED<\/a>, companies should also review the European Commission\u2019s EUDAMED resources.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n    <style>\n        .kk-eudamed-global-wrap {\n            font-family: Inter, Arial, sans-serif;\n            background: linear-gradient(135deg, #f5f9ff 0%, #ffffff 45%, #eef6ff 100%);\n            padding: 70px 20px;\n            color: #102033;\n        }\n\n        .kk-eudamed-global {\n            max-width: 1180px;\n            margin: 0 auto;\n        }\n\n        .kk-hero-grid {\n            display: grid;\n            grid-template-columns: 1.1fr 0.9fr;\n            gap: 36px;\n            align-items: center;\n        }\n\n        .kk-badge {\n            display: inline-flex;\n            align-items: center;\n            gap: 8px;\n            background: #e8f2ff;\n            color: #075caa;\n            padding: 8px 14px;\n            border-radius: 999px;\n            font-size: 13px;\n            font-weight: 700;\n            margin-bottom: 18px;\n        }\n\n        .kk-hero-title {\n            font-size: clamp(34px, 5vw, 58px);\n            line-height: 1.05;\n            margin: 0 0 20px;\n            letter-spacing: -1.8px;\n            color: #0c1d32;\n            font-weight: 850;\n        }\n\n        .kk-hero-title span {\n            color: #0b72d9;\n        }\n\n        .kk-hero-text {\n            font-size: 18px;\n            line-height: 1.7;\n            color: #4a5b70;\n            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1.6;\n        }\n\n        @media (max-width: 920px) {\n            .kk-hero-grid,\n            .kk-form-section {\n                grid-template-columns: 1fr;\n            }\n\n            .kk-card-grid {\n                grid-template-columns: 1fr;\n            }\n\n            .kk-process {\n                grid-template-columns: 1fr 1fr;\n            }\n        }\n\n        @media (max-width: 580px) {\n            .kk-eudamed-global-wrap {\n                padding: 44px 14px;\n            }\n\n            .kk-visual-card,\n            .kk-form-section {\n                padding: 22px;\n                border-radius: 22px;\n            }\n\n            .kk-process {\n                grid-template-columns: 1fr;\n            }\n\n            .kk-hero-actions {\n                flex-direction: column;\n            }\n\n            .kk-btn-primary,\n            .kk-btn-secondary {\n                width: 100%;\n            }\n        }\n    <\/style>\n\n    <section class=\"kk-eudamed-global-wrap\" id=\"eudamed-global-support\">\n        <div class=\"kk-eudamed-global\">\n\n            <div class=\"kk-hero-grid\">\n                <div>\n                    <div class=\"kk-badge\">EUDAMED \u2022 UDI \u2022 MDR \u2022 Bulk XML Support<\/div>\n\n                    <h1 class=\"kk-hero-title\">\n                        EUDAMED Registration Support for <span>Global Medical Device Manufacturers<\/span>\n                    <\/h1>\n\n                    <p class=\"kk-hero-text\">\n                        We help non-EU and international medical device manufacturers prepare structured UDI\/Device data,\n                        validate MDR-related information and generate EUDAMED-ready bulk XML files for faster, cleaner and\n                        more controlled registration workflows.\n                    <\/p>\n\n                    <div class=\"kk-hero-actions\">\n                        <a class=\"kk-btn-primary\" href=\"#kk-eudamed-form\">Get Free 10-Device Check<\/a>\n                        <a class=\"kk-btn-secondary\" href=\"mailto:info@kalitekit.com.tr\">Contact Kalitekit<\/a>\n                    <\/div>\n\n                    <div class=\"kk-trust-row\">\n                        <div class=\"kk-trust-item\">Excel to XML Preparation<\/div>\n                        <div class=\"kk-trust-item\">UDI\/Device Data Review<\/div>\n                        <div class=\"kk-trust-item\">MDR Documentation Check<\/div>\n                    <\/div>\n                <\/div>\n\n                <div class=\"kk-visual-card\">\n                    <div class=\"kk-dashboard-top\">\n                        <div class=\"kk-dot-row\">\n                            <span><\/span><span><\/span><span><\/span>\n                        <\/div>\n                        <div class=\"kk-status\">EUDAMED-ready workflow<\/div>\n                    <\/div>\n\n                    <div class=\"kk-data-line\">\n                        <strong>Basic UDI-DI Mapping<\/strong>\n                        <small>Product families, device models and catalogue references<\/small>\n                        <div class=\"kk-progress\"><span style=\"width:88%\"><\/span><\/div>\n                    <\/div>\n\n                    <div class=\"kk-data-line\">\n                        <strong>UDI-DI \/ GTIN Data Validation<\/strong>\n                        <small>Device identifiers, packaging levels and market data<\/small>\n                        <div class=\"kk-progress\"><span style=\"width:76%\"><\/span><\/div>\n                    <\/div>\n\n                    <div class=\"kk-data-line\">\n                        <strong>Bulk XML Preparation<\/strong>\n                        <small>Structured files for high-volume device registration projects<\/small>\n                        <div class=\"kk-progress\"><span style=\"width:92%\"><\/span><\/div>\n                    <\/div>\n                <\/div>\n            <\/div>\n\n            <div class=\"kk-section\">\n                <div class=\"kk-section-head\">\n                    <h2>What We Do<\/h2>\n                    <p>\n                        A practical service for manufacturers, regulatory teams, authorised representatives and distributors\n                        who need clean, structured and registration-ready EUDAMED device data.\n                    <\/p>\n                <\/div>\n\n                <div class=\"kk-card-grid\">\n                    <div class=\"kk-service-card\">\n                        <div class=\"kk-icon\">\u2713<\/div>\n                        <h3>EUDAMED Data Preparation<\/h3>\n                        <p>\n                            We review and structure your device data including Basic UDI-DI, UDI-DI, device names,\n                            risk class, intended purpose, EMDN code and market information.\n                        <\/p>\n                    <\/div>\n\n                    <div class=\"kk-service-card\">\n                        <div class=\"kk-icon\">\u21bb<\/div>\n                        <h3>Bulk XML Generation<\/h3>\n                        <p>\n                            We convert large Excel-based product catalogues into EUDAMED-ready bulk XML files to reduce\n                            manual work and registration errors.\n                        <\/p>\n                    <\/div>\n\n                    <div class=\"kk-service-card\">\n                        <div class=\"kk-icon\">\u2695<\/div>\n                        <h3>MDR Readiness Review<\/h3>\n                        <p>\n                            We check consistency between your EUDAMED data, Declaration of Conformity, labels, IFU and\n                            technical documentation.\n                        <\/p>\n                    <\/div>\n                <\/div>\n            <\/div>\n\n            <div class=\"kk-section\">\n                <div class=\"kk-section-head\">\n                    <h2>Simple Project Flow<\/h2>\n                    <p>\n                        Designed for companies with multiple devices, large catalogues and limited time before EUDAMED deadlines.\n                    <\/p>\n                <\/div>\n\n                <div class=\"kk-process\">\n                    <div class=\"kk-step\">\n                        <div class=\"kk-step-number\">1<\/div>\n                        <h3>Send Your Data<\/h3>\n                        <p>Share your Excel list, product catalogue or current UDI\/device registration data.<\/p>\n                    <\/div>\n\n                    <div class=\"kk-step\">\n                        <div class=\"kk-step-number\">2<\/div>\n                        <h3>We Review Gaps<\/h3>\n                        <p>We identify missing, inconsistent or risky fields before registration.<\/p>\n                    <\/div>\n\n                    <div class=\"kk-step\">\n                        <div class=\"kk-step-number\">3<\/div>\n                        <h3>Data Mapping<\/h3>\n                        <p>Your product data is mapped into a structured EUDAMED-ready format.<\/p>\n                    <\/div>\n\n                    <div class=\"kk-step\">\n                        <div class=\"kk-step-number\">4<\/div>\n                        <h3>XML Preparation<\/h3>\n                        <p>We prepare bulk XML files and support your registration workflow.<\/p>\n                    <\/div>\n                <\/div>\n            <\/div>\n\n            <div class=\"kk-section\" id=\"kk-eudamed-form\">\n                <div class=\"kk-form-section\">\n                    <div class=\"kk-form-copy\">\n                        <h2>Request a Free 10-Device EUDAMED Data Check<\/h2>\n                        <p>\n                            Send us basic information about your company and device catalogue. We will review up to 10 devices\n                            and show how your data can be prepared for EUDAMED bulk registration.\n                        <\/p>\n\n                        <div class=\"kk-mini-list\">\n                            <div>For non-EU and international manufacturers<\/div>\n                            <div>Suitable for 100+ UDI-DI catalogues<\/div>\n                            <div>Excel, UDI and XML-based workflow<\/div>\n                            <div>Support available in English and Turkish<\/div>\n                        <\/div>\n                    <\/div>\n\n                    <form class=\"kk-lead-form\" action=\"https:\/\/formsubmit.co\/info@kalitekit.com.tr\" method=\"POST\">\n                        <input type=\"hidden\" name=\"_subject\" value=\"New EUDAMED Global Lead - Kalitekit\">\n                        <input type=\"hidden\" name=\"_captcha\" value=\"false\">\n                        <input type=\"hidden\" name=\"_template\" value=\"table\">\n                        <input type=\"hidden\" name=\"_next\" value=\"https:\/\/www.kalitekit.com.tr\/tesekkurler\/\">\n\n                        <input type=\"text\" name=\"Company Name\" placeholder=\"Company Name\" required>\n                        <input type=\"text\" name=\"Contact Person\" placeholder=\"Contact Person\" required>\n                        <input type=\"email\" name=\"Email\" placeholder=\"Business Email\" required>\n\n                        <select name=\"Country\" required>\n                            <option value=\"\">Select Country \/ Region<\/option>\n                            <option value=\"United States\">United States<\/option>\n                            <option value=\"United Kingdom\">United Kingdom<\/option>\n                            <option value=\"Canada\">Canada<\/option>\n                            <option value=\"India\">India<\/option>\n                            <option value=\"China\">China<\/option>\n                            <option value=\"South Korea\">South Korea<\/option>\n                            <option value=\"Middle East\">Middle East<\/option>\n                            <option value=\"Other\">Other<\/option>\n                        <\/select>\n\n                        <select name=\"Estimated Number of UDI-DIs\" required>\n                            <option value=\"\">Estimated Number of UDI-DIs<\/option>\n                            <option value=\"1-50\">1 - 50<\/option>\n                            <option value=\"51-100\">51 - 100<\/option>\n                            <option value=\"101-500\">101 - 500<\/option>\n                            <option value=\"501-1000\">501 - 1000<\/option>\n                            <option value=\"1000+\">1000+<\/option>\n                        <\/select>\n\n                        <select name=\"Service Needed\" required>\n                            <option value=\"\">What do you need?<\/option>\n                            <option value=\"EUDAMED data preparation\">EUDAMED data preparation<\/option>\n                            <option value=\"Bulk XML preparation\">Bulk XML preparation<\/option>\n                            <option value=\"UDI \/ Basic UDI-DI review\">UDI \/ Basic UDI-DI review<\/option>\n                            <option value=\"MDR documentation readiness review\">MDR documentation readiness review<\/option>\n                            <option value=\"Not sure yet\">Not sure yet<\/option>\n                        <\/select>\n\n                        <textarea name=\"Message\" placeholder=\"Briefly describe your devices, current status and target market.\"><\/textarea>\n\n                        <button class=\"kk-submit\" type=\"submit\">Request Free Data Check<\/button>\n\n                        <div class=\"kk-disclaimer\">\n                            Kalitekit provides EUDAMED data preparation, UDI\/device registration support and MDR documentation review.\n                            We do not act as an EU Authorised Representative, Notified Body or Competent Authority.\n                            Final submission remains under the responsibility of the manufacturer, authorised representative or relevant economic operator.\n                        <\/div>\n                    <\/form>\n                <\/div>\n            <\/div>\n\n            <div class=\"kk-bottom-note\">\n                Kalitekit helps medical device companies convert complex product catalogues into structured,\n                EUDAMED-ready data and bulk XML files.\n            <\/div>\n\n        <\/div>\n    <\/section>","protected":false},"excerpt":{"rendered":"<p>EUDAMED bulk XML preparation is a critical step for medical device manufacturers, authorised representatives and exporters who need to organise [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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