{"id":1934,"date":"2020-07-07T09:54:22","date_gmt":"2020-07-07T09:54:22","guid":{"rendered":"https:\/\/ardenneiratherm.com\/certifications\/"},"modified":"2026-01-15T17:30:17","modified_gmt":"2026-01-15T17:30:17","slug":"certificates","status":"publish","type":"page","link":"https:\/\/ardenneiratherm.com\/ko\/certificates\/","title":{"rendered":"\uc778\uc99d"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1934\" class=\"elementor elementor-1934 elementor-291\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c610dbd e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"c610dbd\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;slideInDown&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7a118e9e elementor-widget elementor-widget-heading\" data-id=\"7a118e9e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">\ud3f0 \uc544\ub974\ub374 \uc774\ub77c\uc7a0 1000 WBH wIRA \uc628\uc5f4 \uce58\ub8cc \uae30\uae30 \uc778\uc99d\uc11c<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1acf5629 elementor-widget elementor-widget-text-editor\" data-id=\"1acf5629\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<div id=\"model-response-message-contentr_4610a1d6d26df477\" class=\"markdown markdown-main-panel stronger enable-updated-hr-color\" dir=\"ltr\" aria-live=\"polite\" aria-busy=\"false\"><p data-path-to-node=\"0\">\ud3f0 \uc544\ub974\ub374 \uc774\ub77c\uc7a0 1000 \uc804\uc2e0 \uc628\uc5f4 \uce58\ub8cc(WBH) wIRA \uc7a5\ube44\ub294 \uad6d\uc81c \ubc0f \uc9c0\uc5ed \ud45c\uc900\uacfc \uaddc\uc815\uc744 \uc900\uc218\ud558\uae30 \uc704\ud574 \uc5c4\uaca9\ud55c \ud14c\uc2a4\ud2b8\uc640 \ud3ec\uad04\uc801\uc778 \uc778\uc99d\uc744 \uac70\ucce4\uc73c\uba70, \uc774\ub97c \ud1b5\ud574 \ud1b5\ud569 \uc554 \uce58\ub8cc\uc5d0 \ub300\ud55c &lt;strong&gt;\uc548\uc804\uc131, \ud488\uc9c8 \ubc0f \ud6a8\ub2a5&lt;\/strong&gt;\uc744 \ubcf4\uc7a5\ud569\ub2c8\ub2e4.<\/p><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3a695dd7 e-flex e-con-boxed e-con e-parent\" data-id=\"3a695dd7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-23424373 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"23424373\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;slideInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\ud3f0 \uc544\ub974\ub374 \uc774\ub77c\uc7a0 1000 WBH wIRA \uc628\uc5f4 \uce58\ub8cc \uae30\uae30 \uc0c1\uc138 \uc778\uc99d \ud604\ud669<\/h2>\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-26befc31 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"26befc31\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;slideInUp&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1d2266a8 elementor-widget elementor-widget-heading\" data-id=\"1d2266a8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">\uc758\ub8cc\uae30\uae30 \ud488\uc9c8 \uacbd\uc601 \uc2dc\uc2a4\ud15c\uc5d0 \ub300\ud55c UNI CEI EN ISO 13485 \ud488\uc9c8 \uc778\uc99d<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5e38d712 elementor-widget elementor-widget-text-editor\" data-id=\"5e38d712\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\">\ud3f0 \uc544\ub974\ub374 \uc774\ub77c\uc7a0 1000 WBH wIRA \uc628\uc5f4 \uce58\ub8cc \uae30\uae30\ub294 <a href=\"[https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/Certificate_ISO13485_2025-von-Ardenne-Iratherm-1000-WBH-wIRA-hyperthermia-device.pdf](https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/Certificate_ISO13485_2025-von-Ardenne-Iratherm-1000-WBH-wIRA-hyperthermia-device.pdf)\" target=\"_blank\" rel=\"noopener\">UNI EN ISO 13485 \ud488\uc9c8 \uacbd\uc601 \uc2dc\uc2a4\ud15c \uc778\uc99d<\/a>\uc744 \ubcf4\uc720\ud558\uace0 \uc788\uc74c\uc744 \uc790\ub791\uc2a4\ub7fd\uac8c \uc0dd\uac01\ud569\ub2c8\ub2e4.<\/p><p style=\"text-align: left;\">\uc774 \uc778\uc99d\uc11c\ub294 <strong>Von Ardenne Institut f\u00fcr Angewandte Medizinische Forschung GmbH<\/strong>\uac00 <strong>DIN EN <a href=\"https:\/\/www.iso.org\/standard\/59752.html\" target=\"_blank\" rel=\"noopener\">ISO 13485<\/a>:2021-12 (ISO 13485:2016)<\/strong>\uc758 \uc694\uad6c \uc0ac\ud56d\uc744 \ucda9\uc871\ud558\ub294 <strong>\ud488\uc9c8 \uacbd\uc601 \uc2dc\uc2a4\ud15c(QMS)<\/strong>\uc744 \uad6c\ucd95\ud558\uace0 \uc720\uc9c0\ud558\uace0 \uc788\uc74c\uc744 \uc785\uc99d\ud569\ub2c8\ub2e4.<\/p><p style=\"text-align: left;\">ISO 13485\ub294 \uace0\uac1d\uc758 \uc694\uad6c \uc0ac\ud56d \ubc0f \uad00\ub828 \uaddc\uc81c \uc694\uac74\uc744 \uc9c0\uc18d\uc801\uc73c\ub85c \ucda9\uc871\ud558\ub294 \uc758\ub8cc\uae30\uae30 \ubc0f \uad00\ub828 \uc11c\ube44\uc2a4\ub97c \uc81c\uacf5\ud560 \uc218 \uc788\ub294 \ub2a5\ub825\uc744 \uc870\uc9c1\uc774 \uc785\uc99d\ud574\uc57c \ud558\ub294 \uad6d\uc81c\uc801\uc73c\ub85c \uc778\uc815\ub41c \ud488\uc9c8 \uacbd\uc601 \uc2dc\uc2a4\ud15c \ud45c\uc900\uc785\ub2c8\ub2e4.<\/p><p style=\"text-align: left;\">\ud3f0 \uc544\ub974\ub374 \uc5f0\uad6c\uc18c\uc5d0 \uc788\uc5b4 \uc774 \uc778\uc99d\uc740 \uc124\uacc4\uc640 \uac1c\ubc1c\ubd80\ud130 \uc0dd\uc0b0, \uc124\uce58 \ubc0f \uc11c\ube44\uc2a4\uc5d0 \uc774\ub974\uae30\uae4c\uc9c0 \uc774\ub77c\uc7a0 1000 WBH wIRA \uc628\uc5f4 \uce58\ub8cc \uae30\uae30\uc758 \uc804\uccb4 \uc218\uba85 \uc8fc\uae30 \ub3d9\uc548 \uc138\uc2ec\ud55c \ud488\uc9c8 \uad00\ub9ac\ub97c \uc218\ud589\ud558\uaca0\ub2e4\ub294 \ub2f9\uc0ac\uc758 \uc57d\uc18d\uc744 \uac15\uc870\ud569\ub2c8\ub2e4. \uc774\ub294 \ud658\uc790\uc758 \uc548\uc804\uacfc \uc81c\ud488\uc758 \uc6b0\uc218\uc131\uc744 \ud5a5\ud55c \ub2f9\uc0ac\uc758 \ud5cc\uc2e0\uc5d0 \ub300\ud55c \uadfc\ubcf8\uc801\uc778 \ubcf4\uc99d\uc774\uba70, \uc6b4\uc601 \ud504\ub85c\uc138\uc2a4\ub97c \uc704\ud55c \uacac\uace0\ud55c \ud504\ub808\uc784\uc6cc\ud06c\ub97c \uad6c\ucd95\ud569\ub2c8\ub2e4.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6ef86f7b elementor-widget elementor-widget-image\" data-id=\"6ef86f7b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"635\" height=\"906\" src=\"https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/ISO-13485-certificate-von-Ardenne-Medical-Institute-Dresden.jpg\" class=\"attachment-large size-large wp-image-2963\" alt=\"ISO 13485 certificate von Ardenne Medical Institute Dresden\" srcset=\"https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/ISO-13485-certificate-von-Ardenne-Medical-Institute-Dresden.jpg 635w, https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/ISO-13485-certificate-von-Ardenne-Medical-Institute-Dresden-210x300.jpg 210w\" sizes=\"(max-width: 635px) 100vw, 635px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3d57bd48 elementor-widget elementor-widget-text-editor\" data-id=\"3d57bd48\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h4>\uc8fc\uc694 \uad00\ub828 \uc0ac\ud56d:<\/h4>\n<ul>\n\u00a0\t<li><strong>\uc778\uc99d \uae30\uc5c5:<\/strong> \ubcf8 \uc778\uc99d\uc11c\ub294 \ub3c5\uc77c \ub4dc\ub808\uc2a4\ub374\uc5d0 \uc704\uce58\ud55c <strong>Von Ardenne Institut f\u00fcr Angewandte Medizinische Forschung GmbH<\/strong>\uc5d0 \ubc1c\uae09\ub418\uc5c8\uc2b5\ub2c8\ub2e4.<\/li>\n\u00a0\t<li><strong>\ub2ec\uc131 \ud45c\uc900:<\/strong> \ud574\ub2f9 \uae30\uc5c5\uc740 <strong>SLG Pr\u00fcf- und Zertifizierungs GmbH<\/strong>\ub85c\ubd80\ud130 <strong>ISO 13485<\/strong> \ud45c\uc900 \uc900\uc218 \uc778\uc99d\uc744 \ubc1b\uc558\uc2b5\ub2c8\ub2e4.<\/li>\n\u00a0\t<li><strong>\uc778\uc99d \ubc94\uc704:<\/strong> \ud488\uc9c8 \uacbd\uc601 \uc2dc\uc2a4\ud15c(QMS)\uc740 <strong>\uc804\uc2e0 \uc628\uc5f4 \uce58\ub8cc \uc2dc\uc2a4\ud15c\uc758 \uc81c\uc870, \uc0dd\uc0b0, \uc720\uc9c0\ubcf4\uc218 \ubc0f \uc720\ud1b5<\/strong>\ubfd0\ub9cc \uc544\ub2c8\ub77c <strong>\uc0b0\uc18c \ubc1c\uc0dd\uae30 \ubc0f \uad00\ub828 \uc561\uc138\uc11c\ub9ac\uc758 \uc720\uc9c0\ubcf4\uc218 \ubc0f \ubb34\uc5ed<\/strong> \ubc94\uc704\ub97c \ud3ec\ud568\ud569\ub2c8\ub2e4.<\/li>\n\u00a0\t<li><strong>\uc720\ud6a8 \uae30\uac04:<\/strong> \ubcf8 \uc778\uc99d\uc11c\uc758 \uc720\ud6a8 \uae30\uac04\uc740 <strong>2025\ub144 8\uc6d4 29\uc77c<\/strong>\ubd80\ud130 <strong>2028\ub144 8\uc6d4 28\uc77c<\/strong>\uae4c\uc9c0\uc785\ub2c8\ub2e4.<\/li>\n<\/ul>\n\uc694\uc57d\ud558\uc790\uba74, \uc774 \uc778\uc99d\uc11c\ub294 \uc758\ub8cc\uae30\uae30 \ubd84\uc57c, \ud2b9\ud788 \uc804\uc2e0 \uc628\uc5f4 \uce58\ub8cc \uc2dc\uc2a4\ud15c\uc5d0 \ub300\ud55c \uae30\uc5c5\uc758 <strong>\ud488\uc9c8 \ubc0f \uc548\uc804<\/strong>\uc5d0 \ub300\ud55c \uc57d\uc18d\uc744 \uc785\uc99d\ud558\ubbc0\ub85c \ub9e4\uc6b0 \uc911\uc694\ud569\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc900\uc218\ub294 \uaddc\uc81c \ubaa9\uc801\ubfd0\ub9cc \uc544\ub2c8\ub77c \uace0\uac1d\uacfc \uc758\ub8cc \uc81c\uacf5\uc790 \uac04\uc758 \uc2e0\ub8b0\ub97c \uad6c\ucd95\ud558\ub294 \ub370 \uc788\uc5b4 \ud544\uc218\uc801\uc785\ub2c8\ub2e4.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5fc41c02 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"5fc41c02\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;slideInUp&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4aaa4f77 elementor-widget elementor-widget-heading\" data-id=\"4aaa4f77\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">CE- \uc720\ub7fd \uc801\ud569\uc131 \uc120\uc5b8 (IRATHERM 1000M)<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-529d6a0b elementor-widget elementor-widget-text-editor\" data-id=\"529d6a0b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\">\uc758\ub8cc\uae30\uae30\uc5d0 \ub300\ud55c <a href=\"[https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/EU-Konformitaetserklaerung_MDD_signed_2025-von-Ardenne-Iratherm-1000-WBH-wIRA-hyperthermia-device.pdf](https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/EU-Konformitaetserklaerung_MDD_signed_2025-von-Ardenne-Iratherm-1000-WBH-wIRA-hyperthermia-device.pdf)\"><strong>EU \uc801\ud569\uc131 \uc120\uc5b8(DoC)<\/strong><\/a>\uc785\ub2c8\ub2e4. \uc774\ub294 \uc81c\uc870\uc5c5\uccb4\uc778 <strong>Von Ardenne Institut f\u00fcr Angewandte Medizinische Forschung GmbH<\/strong>\uac00 \ud574\ub2f9 \uc81c\ud488\uc774 \ubaa8\ub4e0 \uad00\ub828 \uc720\ub7fd \uc5f0\ud569(EU) \uaddc\uc815\uc744 \uc900\uc218\ud568\uc744 \ubcf4\uc7a5\ud558\uba70 <strong>\ub2e8\ub3c5 \ucc45\uc784<\/strong>\uc744 \uc9c0\ub294 \uc911\ub300\ud55c \ubc95\uc801 \ubb38\uc11c\uc785\ub2c8\ub2e4.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-323c28d0 elementor-widget elementor-widget-image\" data-id=\"323c28d0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"662\" height=\"946\" src=\"https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/EU-declaration-of-conformity-von-Ardenne-Iratherm-1000-whole-body-hyperthermia-device.jpg\" class=\"attachment-large size-large wp-image-2964\" alt=\"EU declaration of conformity von Ardenne Iratherm 1000 whole body hyperthermia device\" srcset=\"https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/EU-declaration-of-conformity-von-Ardenne-Iratherm-1000-whole-body-hyperthermia-device.jpg 662w, https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/EU-declaration-of-conformity-von-Ardenne-Iratherm-1000-whole-body-hyperthermia-device-210x300.jpg 210w\" sizes=\"(max-width: 662px) 100vw, 662px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6efff3bb elementor-widget elementor-widget-text-editor\" data-id=\"6efff3bb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h4 style=\"text-align: left;\">\uc8fc\uc694 \uad00\ub828 \uc0ac\ud56d:<\/h4>\n<ul style=\"text-align: left;\">\n\u00a0\t<li><strong>\ubc95\uc801 \uc900\uc218 \ubc0f CE \ub9c8\ud06c:<\/strong> \uc801\ud569\uc131 \uc120\uc5b8(DoC)\uc740 \uc81c\ud488\uc5d0 <strong>CE \ub9c8\ud06c<\/strong>\ub97c \ubd80\ucc29\ud558\uae30 \uc704\ud55c \ubc95\uc801 \uc804\uc81c \uc870\uac74\uc774\uba70, \uc774\ub294 EU \uc2dc\uc7a5\uc5d0 \uc758\ub8cc\uae30\uae30\ub97c \ucd9c\uc2dc\ud558\uae30 \uc704\ud574 \ud544\uc218\uc801\uc785\ub2c8\ub2e4. \uc81c\uc870\uc5c5\uccb4\ub294 \uc11c\uba85\uc744 \ud1b5\ud574 \ubcf8 \uc7a5\ube44\uac00 \ub2e4\uc74c \uc0ac\ud56d\uc744 \uc900\uc218\ud568\uc744 \uc778\uc99d\ud569\ub2c8\ub2e4:\n<ul>\n\u00a0\t<li><strong>\uc9c0\uce68 93\/42\/EEC (\uc758\ub8cc\uae30\uae30 \uc9c0\uce68)<\/strong>.<\/li>\n\u00a0\t<li><strong>\uc9c0\uce68 2011\/65\/EU (RoHS \uc9c0\uce68)<\/strong>, \uc720\ud574 \ubb3c\uc9c8 \uc81c\ud55c\uc5d0 \uad00\ud55c \uaddc\uc815.<\/li>\n<\/ul>\n<\/li>\n\u00a0\t<li><strong>\uc778\uc99d \uc81c\ud488:<\/strong> \ubcf8 \uc120\uc5b8\uc740 \uad6c\uccb4\uc801\uc73c\ub85c <strong>Type IRATHERM 1000M<\/strong>\uc73c\ub85c \uc2dd\ubcc4\ub418\ub294 <strong>\uc804\uc2e0 \uc628\uc5f4 \uce58\ub8cc \uc2dc\uc2a4\ud15c<\/strong>\uc744 \ub300\uc0c1\uc73c\ub85c \ud569\ub2c8\ub2e4.<\/li>\n\u00a0\t<li><strong>\uc0ac\uc6a9 \ubaa9\uc801:<\/strong> \ubcf8 \uc7a5\ube44\ub294 <strong>\uc801\uc678\uc120 A \ubc29\uc0ac\uc120\uc744 \uc774\uc6a9\ud55c \uacbd\uc99d \ubc0f \uc911\ub4f1\ub3c4 \uc804\uc2e0 \uc628\uc5f4 \uce58\ub8cc<\/strong>\ub97c \ubaa9\uc801\uc73c\ub85c \ud569\ub2c8\ub2e4.<\/li>\n\u00a0\t<li><strong>\ub4f1\uae09 \ubd84\ub958:<\/strong> \ubcf8 \uc7a5\ube44\ub294 <strong>Class IIa<\/strong>\ub85c \ubd84\ub958\ub429\ub2c8\ub2e4(\uc9c0\uce68 93\/42\/EEC\uc758 \ubd80\uc18d\uc11c IX \uaddc\uce59 9\uc5d0 \uc758\uac70).\n<ul>\n\u00a0\t<li><em>Class IIa \uae30\uae30\ub294 <strong>\uc800\uc704\ud5d8 \ub0b4\uc9c0 \uc911\uc704\ud5d8<\/strong> \uc218\uc900\uc73c\ub85c \uac04\uc8fc\ub418\uba70, \uc801\ud569\uc131 \ud3c9\uac00\ub97c \uc704\ud574 \uc778\uc99d \uae30\uad00(Notified Body, \ub3c5\ub9bd\uc801\uc778 \uc81c3\uc790 \uae30\uad00)\uc758 \ucc38\uc5ec\uac00 \ud544\uc694\ud569\ub2c8\ub2e4.<\/em><\/li>\n<\/ul>\n<\/li>\n\u00a0\t<li><strong>\uc778\uc99d \uae30\uad00 \ucc38\uc5ec:<\/strong> \uc801\ud569\uc131 \uc808\ucc28\uc5d0\ub294 \uc778\uc99d \uae30\uad00\uc778 <strong>SLG Pr\u00fcf- und Zertifizierungs GmbH (CE 0494)<\/strong>\uac00 \ucc38\uc5ec\ud588\uc2b5\ub2c8\ub2e4.<\/li>\n\u00a0\t<li><strong>\uc720\ud6a8 \uae30\uac04:<\/strong> \ubcf8 \uc120\uc5b8\uc740 <strong>2025-08-29<\/strong> \ub2f9\uc77c \ub610\ub294 \uadf8 \uc774\ud6c4\uc5d0 \uc0dd\uc0b0\ub41c \ubaa8\ub4e0 \ud574\ub2f9 \ubaa8\ub378\uc5d0 \uc801\uc6a9\ub418\uba70, \ud2b9\uc815 <strong>EC \uc778\uc99d\uc11c 25-P-Schu-0036 (109963N5)<\/strong>\uacfc \uc5f0\uacc4\ud558\uc5ec <strong>2026-09-30<\/strong>\uae4c\uc9c0 \uc720\ud6a8\ud569\ub2c8\ub2e4.<\/li>\n\u00a0\t<li><strong>\ucd94\uc801\uc131 \ubc0f \ud45c\uc900:<\/strong> \ub2e4\uc591\ud55c \uad00\ub828 \ud45c\uc900(EN ISO 13485:2021 \ub4f1)\uc758 \uc0ac\uc6a9\uc744 \ud655\uc778\ud558\uba70, EU \ub370\uc774\ud130\ubca0\uc774\uc2a4\uc5d0\uc11c \uc81c\uc870\uc5c5\uccb4\uc640 \uc7a5\ube44\ub97c \ucd94\uc801\ud558\uae30 \uc704\ud55c \uace0\uc720 \uc2dd\ubcc4\uc790(<strong>SRN: DE-MF-000011313<\/strong> \ubc0f <strong>EUDAMED-DI: B-DEMF000011313000005218H<\/strong>)\ub97c \ud3ec\ud568\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n<p style=\"text-align: left;\">\ubcf8\uc9c8\uc801\uc73c\ub85c EU \uc801\ud569\uc131 \uc120\uc5b8\uc740 <strong>IRATHERM 1000M<\/strong>\uc774 \uc548\uc804\ud558\uace0 \uc758\ub3c4\ud55c \ub300\ub85c \uc131\ub2a5\uc744 \ubc1c\ud718\ud558\uba70, \uc758\ub8cc\uae30\uae30\uc5d0 \ub300\ud55c \ubaa8\ub4e0 \uc720\ub7fd \ubcf4\uac74 \ubc0f \uc548\uc804 \uc694\uad6c \uc0ac\ud56d\uc744 \uc900\uc218\ud55c\ub2e4\ub294 \uc81c\uc870\uc5c5\uccb4\uc758 \uacf5\uc2dd\uc801\uc778 \uc57d\uc18d\uc785\ub2c8\ub2e4.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-705c70a8 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"705c70a8\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;slideInUp&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-59048340 elementor-widget elementor-widget-heading\" data-id=\"59048340\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;none&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/NB-ConfirmationLetter_2026-MDR-von-Ardenne-Iratherm-1000-WBH-wIRA-hyperthermia-device.pdf\">\uc778\uc99d \uae30\uad00(NB) \ud655\uc778\uc11c (MDR \uc804\ud658)<\/a><\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7723f611 elementor-widget elementor-widget-image\" data-id=\"7723f611\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"638\" height=\"906\" src=\"https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/MDR-von-Ardenne-Iratherm-1000-WBH-wIRA-device-p1.jpg\" class=\"attachment-large size-large wp-image-2971\" alt=\"MDR von Ardenne Iratherm 1000 WBH wIRA device\" srcset=\"https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/MDR-von-Ardenne-Iratherm-1000-WBH-wIRA-device-p1.jpg 638w, https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/MDR-von-Ardenne-Iratherm-1000-WBH-wIRA-device-p1-211x300.jpg 211w\" sizes=\"(max-width: 638px) 100vw, 638px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-658310c5 elementor-widget elementor-widget-text-editor\" data-id=\"658310c5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>\uc774 \uc11c\uc2e0\uc740 \uc0c8\ub85c\uc6b4 <strong>\uc758\ub8cc\uae30\uae30 \uaddc\uc815(<a href=\"https:\/\/www.medical-device-regulation.eu\/download-mdr\/\" target=\"_blank\" rel=\"noopener\">MDR<\/a>, EU 2017\/745)<\/strong>\uc73c\ub85c\uc758 \uc804\ud658 \uccb4\uc81c\ud558\uc5d0\uc11c \ud574\ub2f9 \uc7a5\ube44\uc758 \uc9c0\uc18d\uc801\uc778 \uc2dc\uc7a5 \uc720\ud1b5\uc744 \ubcf4\uc7a5\ud558\uae30 \uc704\ud55c \ud575\uc2ec \ubb38\uc11c\uc785\ub2c8\ub2e4.<\/p><ul><li><strong>MDR \uc804\ud658 \uc0c1\ud0dc:<\/strong> \uc778\uc99d \uae30\uad00(NB 0494, SLG Pr\u00fcf- und Zertifizierungs GmbH)\uc740 \uc81c\uc870\uc5c5\uccb4\uac00 MDR\uc5d0 \ub530\ub978 \uacf5\uc2dd \uc2e0\uccad\uc11c\ub97c \uc81c\ucd9c\ud558\uace0 \uc11c\uba74 \ud569\uc758\uc11c\uc5d0 \uc11c\uba85\ud588\uc74c\uc744 \ud655\uc778\ud569\ub2c8\ub2e4.<\/li><li><strong>\uc720\ud6a8 \uae30\uac04 \uc5f0\uc7a5:<\/strong> \uc774 \ud655\uc778\uc11c\ub294 MDD \uc778\uc99d \uc7a5\ube44\uc778 <strong>IRATHERM\u00ae1000M<\/strong>\uc774 \uaddc\uc815(EU) 2023\/607\uc5d0 \uc758\ud574 \uc124\uc815\ub41c \uc5f0\uc7a5\ub41c \uc804\ud658 \uae30\uac04\uc758 \ud61c\ud0dd\uc744 \ubc1b\uc744 \uc218 \uc788\ub3c4\ub85d \ud558\ubbc0\ub85c \ub9e4\uc6b0 \uc911\uc694\ud569\ub2c8\ub2e4.<\/li><li><strong>MDR \uc900\uc218 \ub9c8\uac10\uc77c:<\/strong> \uc774 <strong>Class IIa<\/strong> \uc7a5\ube44\uac00 \uc0c8\ub85c\uc6b4 MDR\uc5d0 \ub530\ub77c \uc644\uc804\ud788 \uc900\uc218\ud558\uace0 \uc778\uc99d\uc744 \ubc1b\uc544\uc57c \ud558\ub294 \ub9c8\uac10\uc77c\uc740 <strong>2028\ub144 12\uc6d4 31\uc77c<\/strong>\uc785\ub2c8\ub2e4.<\/li><li><strong>\uc0ac\ud6c4 \uad00\ub9ac:<\/strong> \uc778\uc99d \uae30\uad00(NB)\uc740 \uc774 \uc804\ud658 \uae30\uac04 \ub3d9\uc548 \uad00\ub828 \uc9c0\uce68\uc5d0 \ub530\ub77c \ud574\ub2f9 \uc7a5\ube44\uc5d0 \ub300\ud55c \uc801\uc808\ud55c \uc0ac\ud6c4 \uad00\ub9ac\ub97c \uc218\ud589\ud560 \ucc45\uc784\uc774 \uc788\uc74c\uc744 \ud655\uc778\ud569\ub2c8\ub2e4.<\/li><li><strong>\uc720\ud6a8\uc131:<\/strong> \uc774 \uc11c\uc2e0 \uc790\uccb4\ub294 <strong>2026\ub144 9\uc6d4 30\uc77c<\/strong>\uae4c\uc9c0 \uc720\ud6a8\ud569\ub2c8\ub2e4.<\/li><\/ul><h3 style=\"text-align: center;\">\u00a0<\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ebd7f1a elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"ebd7f1a\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;zoomIn&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: center;\">\uc694\uc57d\ud558\uc790\uba74, \ud574\ub2f9 \ubb38\uc11c\ub4e4\uc740 \uc774\ub77c\uc7a0(IRATHERM) 1000\uc774 EU \ub0b4\uc5d0\uc11c \ubc95\uc801 \uaddc\uaca9\uc744 \uc900\uc218\ud558\ub294 <strong>Class IIa \uc758\ub8cc\uae30\uae30<\/strong>\uc784\uc744 \ud655\uc778\ud558\uba70, \uc81c\uc870\uc5c5\uccb4\uac00 \ub354 \uc5c4\uaca9\ud574\uc9c4 \uc0c8\ub85c\uc6b4 MDR \uc694\uad6c \uc0ac\ud56d\uc5d0 \ub530\ub77c \uc778\uc99d\uc744 \uc801\uadf9\uc801\uc73c\ub85c \uc9c4\ud589\ud558\uace0 \uc788\uc74c\uc744 \uc785\uc99d\ud569\ub2c8\ub2e4. \uc774\ub97c \ud1b5\ud574 2028\ub144 \ub9d0\uae4c\uc9c0 \uc2dc\uc7a5 \uc9c4\ucd9c \uad8c\ud55c\uc744 \ud655\ubcf4\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2cfaaec8 elementor-invisible elementor-widget elementor-widget-image\" data-id=\"2cfaaec8\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;zoomInUp&quot;}\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/von-Ardenne-Iratherm-10000-WBH-wIRA-hyperthermia-device-certificates.jpg\" title=\"\" alt=\"von Ardenne Iratherm 10000 WBH wIRA hyperthermia-device-certificates\" loading=\"lazy\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>\ud3f0 \uc544\ub974\ub374 \uc774\ub77c\uc7a0 1000 WBH wIRA \uc628\uc5f4 \uce58\ub8cc \uae30\uae30 \uc778\uc99d\uc11c \ud3f0 \uc544\ub974\ub374 \uc774\ub77c\uc7a0 1000 \uc804\uc2e0 \uc628\uc5f4 \uce58\ub8cc(WBH) wIRA \uc7a5\ube44\ub294 \uad6d\uc81c \ubc0f \uc9c0\uc5ed \ud45c\uc900\uacfc \uaddc\uc815\uc744 \uc900\uc218\ud558\uae30 \uc704\ud574 \uc5c4\uaca9\ud55c \ud14c\uc2a4\ud2b8\uc640 \ud3ec\uad04\uc801\uc778 \uc778\uc99d\uc744 \uac70\ucce4\uc73c\uba70, \uc774\ub97c \ud1b5\ud574 \ud1b5\ud569 \uc554 \uce58\ub8cc\uc5d0 \ub300\ud55c &lt;strong&gt;\uc548\uc804\uc131, \ud488\uc9c8 \ubc0f \ud6a8\ub2a5&lt;\/strong&gt;\uc744 \ubcf4\uc7a5\ud569\ub2c8\ub2e4. \ud3f0 \uc544\ub974\ub374 \uc774\ub77c\uc7a0 1000 WBH wIRA \uc628\uc5f4 \uce58\ub8cc \uae30\uae30 \uc0c1\uc138 \uc778\uc99d \ud604\ud669 \uc758\ub8cc\uae30\uae30<br \/><a class=\"moretag\" href=\"https:\/\/ardenneiratherm.com\/ko\/certificates\/\">+ Read More<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"templates\/page-fullwidth_template.php","meta":{"footnotes":""},"class_list":["post-1934","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/ardenneiratherm.com\/ko\/wp-json\/wp\/v2\/pages\/1934","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ardenneiratherm.com\/ko\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/ardenneiratherm.com\/ko\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/ardenneiratherm.com\/ko\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ardenneiratherm.com\/ko\/wp-json\/wp\/v2\/comments?post=1934"}],"version-history":[{"count":0,"href":"https:\/\/ardenneiratherm.com\/ko\/wp-json\/wp\/v2\/pages\/1934\/revisions"}],"wp:attachment":[{"href":"https:\/\/ardenneiratherm.com\/ko\/wp-json\/wp\/v2\/media?parent=1934"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}