{"id":34046,"date":"2024-06-25T11:55:31","date_gmt":"2024-06-25T09:55:31","guid":{"rendered":"https:\/\/gynemed.de\/2024\/06\/25\/gm501-gradienten-ce-kennzeichnung-nach-neuer-mdr\/"},"modified":"2024-06-25T11:59:54","modified_gmt":"2024-06-25T09:59:54","slug":"gm501-gradienten-ce-kennzeichnung-nach-neuer-mdr","status":"publish","type":"post","link":"https:\/\/gynemed.de\/en\/2024\/06\/25\/gm501-gradienten-ce-kennzeichnung-nach-neuer-mdr\/","title":{"rendered":"GM501 Gradients CE marking according to new MDR"},"content":{"rendered":"<p>Valued customer,<\/p>\n<p>We are very pleased to announce that <strong>GM501 Gradient 45%\/ 90%\/ 100%<\/strong> is now \u00a0CE-marked in conformity with the new European Medical Device Regulation (MDR, 2014\/745.<\/p>\n<p><strong><span>CE marking of the product according to the MDR does result in the following changes:<\/span><\/strong><\/p>\n<ul>\n<li><span>Use of 3-layered labels <\/span><\/li>\n<li><span>New version of instructions for use<\/span> <a href=\"https:\/\/gynemed.de\/wp-content\/uploads\/2017\/06\/Gebrauchsanweisung_GM501_Gradient_45_90_Multi_330x390_Rev03_00_MDR.pdf\" target=\"_blank\" rel=\"noopener\">(45\/90 Rev03_00)<\/a> <a href=\"https:\/\/gynemed.de\/wp-content\/uploads\/2017\/06\/Gebrauchsanweisung_GM501_Gradient_100_Multi_330x390_Rev03_00_MDR.pdf\" target=\"_blank\" rel=\"noopener\">(100 Rev03_00)<\/a><\/li>\n<li><span>New version of MSDS <\/span><a href=\"https:\/\/gynemed.de\/wp-content\/uploads\/2017\/06\/MSDS_GM501_Gradient_45_90_Rev11_00.pdf\" target=\"_blank\" rel=\"noopener\">(45\/90 Rev11_00)<\/a> <a href=\"https:\/\/gynemed.de\/wp-content\/uploads\/2017\/06\/MSDS_GM501_Gradient-100_Rev10_00.pdf\" target=\"_blank\" rel=\"noopener\">(100 Rev10_00)<\/a><\/li>\n<li><a href=\"https:\/\/gynemed.de\/wp-content\/uploads\/2017\/06\/MDR-748614_QMS_2024_03_15.pdf\" target=\"_blank\" rel=\"noopener\">Certificate<\/a><\/li>\n<\/ul>\n<p><span>If additional information or additional registration actions in your jurisdiction(s) are required, please send your question to<\/span> <a href=\"mailto:ra@gynemed.de\" target=\"_blank\" rel=\"noopener\">ra@gynemed.de<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"Valued customer, We are very pleased to announce that GM501 Gradient 45%\/ 90%\/ 100% is now \u00a0CE-marked in conformity with the new European Medical Device Regulation (MDR, 2014\/745. CE marking of the product according to the MDR does result in the following changes: Use of 3-layered labels New version of instructions for use (45\/90 Rev03_00)","protected":false},"author":4,"featured_media":34043,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post post-type-post post-view- post-scope-","status-publish","post-format-standard","has-post-thumbnail","category-news","clear"],"acf":[],"_links":{"self":[{"href":"https:\/\/gynemed.de\/en\/wp-json\/wp\/v2\/posts\/34046","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gynemed.de\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/gynemed.de\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/gynemed.de\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/gynemed.de\/en\/wp-json\/wp\/v2\/comments?post=34046"}],"version-history":[{"count":3,"href":"https:\/\/gynemed.de\/en\/wp-json\/wp\/v2\/posts\/34046\/revisions"}],"predecessor-version":[{"id":34049,"href":"https:\/\/gynemed.de\/en\/wp-json\/wp\/v2\/posts\/34046\/revisions\/34049"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/gynemed.de\/en\/wp-json\/wp\/v2\/media\/34043"}],"wp:attachment":[{"href":"https:\/\/gynemed.de\/en\/wp-json\/wp\/v2\/media?parent=34046"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/gynemed.de\/en\/wp-json\/wp\/v2\/categories?post=34046"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/gynemed.de\/en\/wp-json\/wp\/v2\/tags?post=34046"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}