{"id":1177,"date":"2022-08-23T13:52:25","date_gmt":"2022-08-23T20:52:25","guid":{"rendered":"https:\/\/shapememordev.wpenginepowered.com\/japan\/?page_id=1177"},"modified":"2023-07-11T16:23:20","modified_gmt":"2023-07-11T23:23:20","slug":"product-clearances","status":"publish","type":"page","link":"https:\/\/www.shapemem.com\/japan\/product-clearances\/","title":{"rendered":"Product Clearances"},"content":{"rendered":"

[vc_row min_height=”550px” content_placement=”middle” custom_bg_type=”image” custom_bg_cover=”cover” custom_bg_repeat=”no-repeat” custom_bg_position=”Center center” nav_skin=”light” consent_include=”include” equal_height=”true” el_design=”{“desktop“:{“padding-top“:“200“,“padding-bottom“:“100“}}” custom_bg_color=”{“solid“:{“id“:“Main accent color“,“color“:“#2a327e“}}” custom_bg_image=”676″][vc_column css_animation=””][vc_heading heading_text=”Active Product Certificates or Regulatory Approvals:” heading_wrapper=”h1″ heading_color=”{“solid“:{“id“:“Light text color“,“color“:“#ffffff“}}” heading_typography=”{“font_family“:“240743169“,“font_size“:“60px“,“line_height“:“1.2em“,“letter_spacing“:“-0.03em“}” responsiveness=”yes” tablet_portrait=”90″ mobile_landscape=”80″ mobile_portrait=”70″ css_animation=””][\/vc_column][\/vc_row][vc_section nav_skin=”light”][vc_row nav_skin=”light” consent_include=”include”][vc_column el_design=”{“desktop“:{“padding-top“:“15“,“padding-right“:“15“,“padding-bottom“:“40“,“padding-left“:“15“}}” css_animation=””][vc_text_element force_color=”yes” css_animation=”” color=”{“id“:“Main accent color“,“color“:“#2a327e“}”]<\/p>\n

\n
\n

IMPEDE\u00ae<\/sup> Embolization Plug<\/h4>\n
    \n
  • United States – 510K #: <\/strong>K181051<\/li>\n
  • Europe (CE) – Annex II Registration #: 530394<\/li>\n
  • Japan – Approval #: 30100BZX00225000<\/li>\n
  • Argentina – Registration #: 1-0047-3110-000807-22-7<\/li>\n
  • Australia – ARTG Identifier #: 386855<\/li>\n
  • Columbia – Registration #: INVIMA 2020DM-0022588<\/li>\n
  • Israel – Registration #: <\/strong>13270440<\/li>\n
  • Mexico – Registration #: 1857C2021 SSA<\/li>\n
  • Serbia – Registration #: 515-02-02673-2018-7<\/li>\n
  • Switzerland – Swiss Authorized Representative Single Registration #: CHRN CHE \u2013 103.645.837<\/li>\n
  • United Kingdom – MHRA Application Reference #: <\/strong>2022020300237075<\/li>\n
  • United Arab Emirates:<\/strong> DRCLAS-2022-005512<\/li>\n
  • Taiwan – Registration #: 036327<\/li>\n
  • Hong Kong – The IMPEDE product family was voluntarily registered.<\/li>\n<\/ul>\n

    IMPEDE-FX Embolization Plug<\/h4>\n
      \n
    • United States – 510K #: <\/strong>K182390<\/li>\n
    • Europe (CE) – Annex II Registration #: 530394<\/li>\n
    • Japan – Approval #: 30100BZX00225000<\/li>\n
    • Argentina – Registration #: 1-0047-3110-000807-22-7<\/li>\n
    • Australia – ARTG Identifier #: 386855<\/li>\n
    • Columbia – Registration #: INVIMA 2020DM-0022588<\/li>\n
    • Israel – Registration #: <\/strong>13270440<\/li>\n
    • Serbia – Registration #: 515-02-00544-2021-7<\/li>\n
    • Switzerland – Swiss Authorized Representative Single Registration #: CHRN CHE \u2013 103.645.837<\/li>\n
    • United Kingdom – MHRA Application Reference #: <\/strong>2022020300237075<\/li>\n
    • United Arab Emirates:<\/strong> DRCLAS-2022-005512<\/li>\n
    • Taiwan – Registration #: 036311<\/li>\n
    • Hong Kong – The IMPEDE product family was voluntarily registered.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n
      \n
      \n

      IMPEDE-FX RapidFill\u00ae<\/sup><\/h4>\n
        \n
      • Europe (CE) – Annex II Registration #: 530394<\/li>\n
      • Australia – ARTG Identifier #: 386855<\/li>\n
      • Columbia – Registration #: INVIMA 2020DM-0022588<\/li>\n
      • Israel – Registration #: <\/strong>13270440<\/li>\n
      • Serbia – Registration #: 515-02-00544-2021-7<\/li>\n
      • Switzerland – Swiss Authorized Representative Single Registration #: CHRN CHE \u2013 103.645.837<\/li>\n
      • United Kingdom – MHRA Application Reference #: <\/strong>2022020300237075<\/li>\n
      • United Arab Emirates:<\/strong> DRCLAS-2022-005512<\/li>\n
      • Taiwan – Registration #: 036388<\/li>\n
      • Hong Kong – The IMPEDE product family was voluntarily registered.<\/li>\n<\/ul>\n

        TrelliX\u00ae <\/sup>Embolic Coil System<\/h4>\n
          \n
        • Europe (CE) – Annex II Registration #: 530394<\/li>\n
        • Israel – Registration #: <\/strong>13270441<\/li>\n
        • Serbia – Registration #: 515-02-03609-2019-7<\/li>\n
        • Switzerland – Swiss Authorized Representative Single Registration #: CHRN CHE \u2013 103.645.837<\/li>\n
        • United Kingdom – MHRA Application Reference #: <\/strong>2022020300237075<\/li>\n<\/ul>\n<\/div>\n<\/div>\n

          [\/vc_text_element][\/vc_column][\/vc_row][\/vc_section]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

          [vc_row min_height=”550px” content_placement=”middle” custom_bg_type=”image” custom_bg_cover=”cover” custom_bg_repeat=”no-repeat” custom_bg_position=”Center center” nav_skin=”light” consent_include=”include” equal_height=”true” el_design=”{“desktop“:{“padding-top“:“200“,“padding-bottom“:“100“}}” custom_bg_color=”{“solid“:{“id“:“Main accent color“,“color“:“#2a327e“}}” custom_bg_image=”676″][vc_column css_animation=””][vc_heading heading_text=”Active Product Certificates or Regulatory Approvals:” heading_wrapper=”h1″ heading_color=”{“solid“:{“id“:“Light text color“,“color“:“#ffffff“}}” heading_typography=”{“font_family“:“240743169“,“font_size“:“60px“,“line_height“:“1.2em“,“letter_spacing“:“-0.03em“}” responsiveness=”yes” tablet_portrait=”90″ mobile_landscape=”80″ mobile_portrait=”70″ css_animation=””][\/vc_column][\/vc_row][vc_section nav_skin=”light”][vc_row nav_skin=”light” consent_include=”include”][vc_column el_design=”{“desktop“:{“padding-top“:“15“,“padding-right“:“15“,“padding-bottom“:“40“,“padding-left“:“15“}}” css_animation=””][vc_text_element force_color=”yes” css_animation=”” color=”{“id“:“Main accent color“,“color“:“#2a327e“}”] IMPEDE\u00ae Embolization Plug United States – 510K #: K181051 Europe (CE) – Annex II Registration #: 530394 Japan – Approval #: 30100BZX00225000 Argentina – Registration #: 1-0047-3110-000807-22-7 Australia – ARTG Identifier #: […]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-1177","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nProduct Clearances - 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