{"id":16391,"date":"2026-07-14T09:55:00","date_gmt":"2026-07-14T09:55:00","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/?page_id=16391"},"modified":"2026-07-14T09:55:06","modified_gmt":"2026-07-14T09:55:06","slug":"eudamed-kaydi-zorunlu-mu","status":"publish","type":"page","link":"https:\/\/www.kalitekit.com.tr\/en\/eudamed-kaydi-zorunlu-mu\/","title":{"rendered":"EUDAMED Kayd\u0131 Sizin \u0130\u00e7in Zorunlu mu?"},"content":{"rendered":"<section class=\"kkec-shell\" aria-labelledby=\"kkec-title\">\n            <div class=\"kkec-accent\" aria-hidden=\"true\"><\/div>\n            <header class=\"kkec-hero\">\n                <div class=\"kkec-brand-row\">\n                    <span class=\"kkec-mark\" aria-hidden=\"true\">\n                        <svg viewbox=\"0 0 48 48\" role=\"img\"><path d=\"M10 25.5 19.5 35 39 14.5\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"6\" stroke-linecap=\"round\" stroke-linejoin=\"round\"\/><\/svg>\n                    <\/span>\n                    <span class=\"kkec-brand\">KaliteKit<\/span>\n                    <span class=\"kkec-badge\">\u00dccretsiz \u00f6n de\u011ferlendirme<\/span>\n                <\/div>\n                <h2 id=\"kkec-title\">EUDAMED Kayd\u0131 Sizin \u0130\u00e7in Zorunlu mu?<\/h2>\n                <p>2 dakikada mevcut durumunuzu kontrol edin. Yan\u0131tlar\u0131n\u0131za g\u00f6re size \u00f6zel aksiyon seviyesini hemen g\u00f6r\u00fcn ve e-posta ile al\u0131n.<\/p>\n                <div class=\"kkec-trust-row\" aria-label=\"Form \u00f6zellikleri\">\n                    <span><i>\u2713<\/i> H\u0131zl\u0131 sonu\u00e7<\/span>\n                    <span><i>\u2713<\/i> E-posta \u00f6zeti<\/span>\n                    <span><i>\u2713<\/i> \u00dccretsiz<\/span>\n                <\/div>\n            <\/header>\n\n            <div class=\"kkec-body\">\n                <div class=\"kkec-progress-wrap\" aria-label=\"\u0130lerleme\">\n                    <div class=\"kkec-progress-label\"><span id=\"kkec-progress-text\">Ad\u0131m 1 \/ 3<\/span><strong id=\"kkec-progress-percent\">%33<\/strong><\/div>\n                    <div class=\"kkec-progress\"><span id=\"kkec-progress-bar\" style=\"width:33%\"><\/span><\/div>\n                <\/div>\n\n                <form id=\"kkec-form\" class=\"kkec-form\" novalidate action=\"\">\n                    <input type=\"hidden\" name=\"action\" value=\"kkec_submit\">\n                    <input type=\"hidden\" name=\"nonce\" value=\"9214730a2d\">\n                    <div class=\"kkec-hp\" aria-hidden=\"true\"><label>Website<input type=\"text\" name=\"website\" tabindex=\"-1\" autocomplete=\"off\"><\/label><\/div>\n\n                    <div class=\"kkec-step is-active\" data-step=\"1\">\n                        <div class=\"kkec-step-heading\">\n                            <span class=\"kkec-step-icon\">1<\/span>\n                            <div><h3>\u0130leti\u015fim bilgileri<\/h3><p>Sonucunuzu size iletebilmemiz i\u00e7in temel bilgilerinizi girin.<\/p><\/div>\n                        <\/div>\n                        <div class=\"kkec-grid kkec-grid-2\">\n                            <label class=\"kkec-field\"><span>Ad soyad *<\/span><input type=\"text\" name=\"full_name\" autocomplete=\"name\" maxlength=\"120\" required placeholder=\"Ad\u0131n\u0131z ve soyad\u0131n\u0131z\"><\/label>\n                            <label class=\"kkec-field\"><span>Firma ad\u0131 *<\/span><input type=\"text\" name=\"company\" autocomplete=\"organization\" maxlength=\"160\" required placeholder=\"Firma unvan\u0131\"><\/label>\n                            <label class=\"kkec-field\"><span>E-posta adresi *<\/span><input type=\"email\" name=\"email\" autocomplete=\"email\" maxlength=\"160\" required placeholder=\"ornek@firma.com\"><\/label>\n                            <label class=\"kkec-field\"><span>Telefon *<\/span><input type=\"tel\" name=\"phone\" autocomplete=\"tel\" maxlength=\"40\" required placeholder=\"05xx xxx xx xx\"><\/label>\n                        <\/div>\n                    <\/div>\n\n                    <div class=\"kkec-step\" data-step=\"2\" hidden>\n                        <div class=\"kkec-step-heading\">\n                            <span class=\"kkec-step-icon\">2<\/span>\n                            <div><h3>Firman\u0131z ve AB pazar\u0131<\/h3><p>Firman\u0131z\u0131n rol\u00fcn\u00fc ve Avrupa Birli\u011fi pazar\u0131ndaki durumunu belirtin.<\/p><\/div>\n                        <\/div>\n                        <div class=\"kkec-grid kkec-grid-2\">\n                                    <label class=\"kkec-field\">\n            <span>Firman\u0131z\u0131n rol\u00fc *<\/span>\n            <select name=\"role\" required>\n                                    <option value=\"\">Se\u00e7iniz<\/option>\n                                    <option value=\"manufacturer\">\u00dcretici<\/option>\n                                    <option value=\"importer\">\u0130thalat\u00e7\u0131<\/option>\n                                    <option value=\"authorised_representative\">Avrupa Yetkili Temsilcisi<\/option>\n                                    <option value=\"system_pack\">Sistem \/ Prosed\u00fcr Paketi \u00dcreticisi<\/option>\n                                    <option value=\"distributor\">Distrib\u00fct\u00f6r<\/option>\n                                    <option value=\"consultant\">Dan\u0131\u015fman \/ Hizmet sa\u011flay\u0131c\u0131<\/option>\n                                    <option value=\"other\">Di\u011fer \/ Emin de\u011filim<\/option>\n                            <\/select>\n        <\/label>\n                                            <label class=\"kkec-field\">\n            <span>AB pazar\u0131na cihaz sunuyor musunuz? *<\/span>\n            <select name=\"eu_market\" required>\n                                    <option value=\"\">Se\u00e7iniz<\/option>\n                                    <option value=\"yes\">Evet, h\u00e2lihaz\u0131rda sunuyoruz<\/option>\n                                    <option value=\"planning\">Hen\u00fcz de\u011fil, planl\u0131yoruz<\/option>\n                                    <option value=\"no\">Hay\u0131r<\/option>\n                                    <option value=\"not_sure\">Emin de\u011filim<\/option>\n                            <\/select>\n        <\/label>\n                                            <label class=\"kkec-field\">\n            <span>\u00dcr\u00fcnleriniz hangi kapsamdad\u0131r? *<\/span>\n            <select name=\"regulation\" required>\n                                    <option value=\"\">Se\u00e7iniz<\/option>\n                                    <option value=\"mdr\">MDR \u2013 T\u0131bbi cihaz<\/option>\n                                    <option value=\"ivdr\">IVDR \u2013 \u0130n vitro tan\u0131 cihaz\u0131<\/option>\n                                    <option value=\"both\">Her ikisi de<\/option>\n                                    <option value=\"legacy\">MDD \/ AIMDD \/ IVDD ge\u00e7i\u015f cihaz\u0131<\/option>\n                                    <option value=\"not_sure\">Emin de\u011filim<\/option>\n                                    <option value=\"none\">T\u0131bbi cihaz \/ IVD de\u011fil<\/option>\n                            <\/select>\n        <\/label>\n                                            <label class=\"kkec-field\">\n            <span>Firman\u0131z AB i\u00e7inde yerle\u015fik mi? *<\/span>\n            <select name=\"eu_established\" required>\n                                    <option value=\"\">Se\u00e7iniz<\/option>\n                                    <option value=\"yes\">Evet<\/option>\n                                    <option value=\"no\">Hay\u0131r, AB d\u0131\u015f\u0131nda yerle\u015fik<\/option>\n                                    <option value=\"not_sure\">Emin de\u011filim<\/option>\n                            <\/select>\n        <\/label>\n                                            <label class=\"kkec-field\">\n            <span>Avrupa Yetkili Temsilciniz var m\u0131? *<\/span>\n            <select name=\"ar_status\" required>\n                                    <option value=\"\">Se\u00e7iniz<\/option>\n                                    <option value=\"yes\">Evet, aktif s\u00f6zle\u015fmemiz var<\/option>\n                                    <option value=\"in_progress\">S\u00fcre\u00e7 devam ediyor<\/option>\n                                    <option value=\"no\">Hay\u0131r<\/option>\n                                    <option value=\"not_applicable\">Uygulanabilir de\u011fil \/ AB i\u00e7inde yerle\u015fi\u011fiz<\/option>\n                                    <option value=\"not_sure\">Emin de\u011filim<\/option>\n                            <\/select>\n        <\/label>\n                                            <label class=\"kkec-field\">\n            <span>EUDAMED SRN numaran\u0131z var m\u0131? *<\/span>\n            <select name=\"srn_status\" required>\n                                    <option value=\"\">Se\u00e7iniz<\/option>\n                                    <option value=\"yes\">Evet<\/option>\n                                    <option value=\"pending\">Ba\u015fvuru yap\u0131ld\u0131 \/ onay bekliyor<\/option>\n                                    <option value=\"no\">Hay\u0131r<\/option>\n                                    <option value=\"not_sure\">Emin de\u011filim<\/option>\n                            <\/select>\n        <\/label>\n                                <\/div>\n                    <\/div>\n\n                    <div class=\"kkec-step\" data-step=\"3\" hidden>\n                        <div class=\"kkec-step-heading\">\n                            <span class=\"kkec-step-icon\">3<\/span>\n                            <div><h3>Cihaz kay\u0131t haz\u0131rl\u0131\u011f\u0131<\/h3><p>Mevcut kay\u0131tlar\u0131n\u0131z\u0131 ve veri haz\u0131rl\u0131k seviyenizi belirtin.<\/p><\/div>\n                        <\/div>\n                        <div class=\"kkec-grid kkec-grid-2\">\n                                    <label class=\"kkec-field\">\n            <span>Cihazlar\u0131n\u0131z EUDAMED\u2019e kaydedildi mi? *<\/span>\n            <select name=\"device_registration\" required>\n                                    <option value=\"\">Se\u00e7iniz<\/option>\n                                    <option value=\"all\">Evet, tamam\u0131 kay\u0131tl\u0131<\/option>\n                                    <option value=\"partial\">K\u0131smen kay\u0131tl\u0131<\/option>\n                                    <option value=\"no\">Hay\u0131r<\/option>\n                                    <option value=\"not_sure\">Emin de\u011filim<\/option>\n                                    <option value=\"not_applicable\">Hen\u00fcz \u00fcr\u00fcn\u00fcm\u00fcz yok \/ uygulanabilir de\u011fil<\/option>\n                            <\/select>\n        <\/label>\n                                            <label class=\"kkec-field\">\n            <span>Kaydedilecek yakla\u015f\u0131k \u00fcr\u00fcn say\u0131s\u0131 *<\/span>\n            <select name=\"device_count\" required>\n                                    <option value=\"\">Se\u00e7iniz<\/option>\n                                    <option value=\"0\">Hen\u00fcz \u00fcr\u00fcn yok<\/option>\n                                    <option value=\"1-10\">1\u201310<\/option>\n                                    <option value=\"11-50\">11\u201350<\/option>\n                                    <option value=\"51-250\">51\u2013250<\/option>\n                                    <option value=\"251-1000\">251\u20131.000<\/option>\n                                    <option value=\"1000+\">1.000 \u00fczeri<\/option>\n                                    <option value=\"not_sure\">Emin de\u011filim<\/option>\n                            <\/select>\n        <\/label>\n                                            <label class=\"kkec-field kkec-span-2\">\n            <span>Basic UDI-DI \/ UDI-DI verileriniz haz\u0131r m\u0131? *<\/span>\n            <select name=\"udi_status\" required>\n                                    <option value=\"\">Se\u00e7iniz<\/option>\n                                    <option value=\"complete\">Evet, tamam\u0131 haz\u0131r ve kontrol edildi<\/option>\n                                    <option value=\"partial\">K\u0131smen haz\u0131r<\/option>\n                                    <option value=\"no\">Hay\u0131r<\/option>\n                                    <option value=\"not_sure\">Emin de\u011filim<\/option>\n                                    <option value=\"not_applicable\">Uygulanabilir de\u011fil<\/option>\n                            <\/select>\n        <\/label>\n                                <\/div>\n\n                        <label class=\"kkec-consent\">\n                            <input type=\"checkbox\" name=\"consent\" value=\"1\" required>\n                            <span>Bilgilerimin EUDAMED \u00f6n de\u011ferlendirmesi, sonu\u00e7 e-postas\u0131 ve talebimle ilgili ileti\u015fim amac\u0131yla i\u015flenmesini kabul ediyorum. <a href=\"https:\/\/www.kalitekit.com.tr\/en\/gizlilik-politikasi\/\" target=\"_blank\" rel=\"noopener\">Ayd\u0131nlatma metni<\/a><\/span>\n                        <\/label>\n                        <p class=\"kkec-disclaimer\">Bu ara\u00e7, verilen yan\u0131tlara dayal\u0131 genel bir \u00f6n de\u011ferlendirme sunar; hukuki veya ba\u011flay\u0131c\u0131 bir uygunluk g\u00f6r\u00fc\u015f\u00fc de\u011fildir. Nihai y\u00fck\u00fcml\u00fcl\u00fck \u00fcr\u00fcn, rol ve ge\u00e7i\u015f h\u00fck\u00fcmlerine g\u00f6re ayr\u0131ca incelenmelidir.<\/p>\n                    <\/div>\n\n                    <div id=\"kkec-form-error\" class=\"kkec-alert kkec-alert-error\" role=\"alert\" hidden><\/div>\n\n                    <div class=\"kkec-actions\">\n                        <button type=\"button\" class=\"kkec-btn kkec-btn-secondary\" id=\"kkec-prev\" hidden>Geri<\/button>\n                        <button type=\"button\" class=\"kkec-btn kkec-btn-primary\" id=\"kkec-next\">Devam et <span>\u2192<\/span><\/button>\n                        <button type=\"submit\" class=\"kkec-btn kkec-btn-primary\" id=\"kkec-submit\" hidden>Sonucumu g\u00f6ster <span>\u2192<\/span><\/button>\n                    <\/div>\n                <input type=\"hidden\" name=\"trp-form-language\" value=\"en\"\/><\/form>\n\n                <div id=\"kkec-result\" class=\"kkec-result\" hidden aria-live=\"polite\"><\/div>\n            <\/div>\n            <footer class=\"kkec-footer-note\">Verileriniz yaln\u0131zca ba\u015fvurunuzun de\u011ferlendirilmesi ve sizinle ileti\u015fim kurulmas\u0131 amac\u0131yla i\u015flenir.<\/footer>\n        <\/section>\n        \n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"","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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