{"id":443,"date":"2015-09-28T15:57:56","date_gmt":"2015-09-28T13:57:56","guid":{"rendered":"https:\/\/marhythe-systems.de\/?page_id=443"},"modified":"2025-11-20T11:48:44","modified_gmt":"2025-11-20T10:48:44","slug":"zertifikate","status":"publish","type":"page","link":"https:\/\/marhythe-systems.de\/en\/das-produkt\/zertifikate\/","title":{"rendered":"Certificates"},"content":{"rendered":"\n

The Matrixmobil \u00ae and the Matrixmobil alpha-synchronizer\u00ae are the only medical devices for the application of Matrix Rhythm Therapy (MaRhyThe \u00ae). Active medical devices are subject to special requirements. These requirements serve to ensure the safety, health and protection of patients and users.
<\/p>\n\n\n\n

As a manufacturer, we have a quality management system and are certified in accordance with EN ISO 13485:2016.<\/p>\n\n\n

\n
\"eg-zertifikat_marhythe\"<\/a>

EC-Certificate<\/p><\/div>\n

Quality Assurance System
Transition MDD to MDR: Product-Directive EU2023\/607 – EU 2017\/607 – EU 2017\/745 MDR, as well as Product Directive 93\/42\/EWG on Medical Devices (MDD), Annex VI (Devices in class IIa or IIb); CL 035504 0015 Rev.00 (for GS 035504 0011 Rev.00) valid till 2028-12-31<\/strong><\/p>\n<\/div>\n

\u00a0<\/div>\n
\n
\"https:\/\/marhythe-systems.de\/wp-content\/uploads\/QM_Certificate_EN-ISO_13485_2022.pdf\"<\/a>

QM-Certificate<\/p><\/div>\n

EN ISO 13485:2016 Medical Devices Quality management systems – Requirements for regulatory purposes –<\/p>\n<\/div>\n

\u00a0<\/div><\/div>
\n
\"CB-Test-Certificate\"<\/a>

CB Test Certificate<\/p><\/div>\n

IEC 60601-1 (ed.3); am1
IEC 60601-1-6 (ed.3);am1
IEC62366 (ed.1);am1<\/p>\n<\/div>\n

\u00a0<\/div>\n
\n
\"Declaration

Declaration of Conformity<\/p><\/div>\n

EC-Declaration
of Conformity<\/p>\n

Matrixmobil<\/a>
Matrixmobil – alpha synchronizer<\/a><\/p>\n<\/div><\/div>

<\/div><\/p>","protected":false},"excerpt":{"rendered":"

The Matrixmobil \u00ae and the Matrixmobil alpha-synchronizer\u00ae are the only medical devices for the application of Matrix Rhythm Therapy (MaRhyThe \u00ae). Active medical devices are subject to special requirements. These requirements serve to ensure the safety, health and protection of patients and users. As a manufacturer, we have a quality management system and are certified […]<\/p>\n","protected":false},"author":8,"featured_media":0,"parent":10,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-443","page","type-page","status-publish","hentry"],"translation":{"provider":"WPGlobus","version":"3.0.2","language":"en","enabled_languages":["de","en"],"languages":{"de":{"title":true,"content":true,"excerpt":false},"en":{"title":true,"content":true,"excerpt":false}}},"_links":{"self":[{"href":"https:\/\/marhythe-systems.de\/en\/wp-json\/wp\/v2\/pages\/443","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/marhythe-systems.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/marhythe-systems.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/marhythe-systems.de\/en\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/marhythe-systems.de\/en\/wp-json\/wp\/v2\/comments?post=443"}],"version-history":[{"count":46,"href":"https:\/\/marhythe-systems.de\/en\/wp-json\/wp\/v2\/pages\/443\/revisions"}],"predecessor-version":[{"id":5524,"href":"https:\/\/marhythe-systems.de\/en\/wp-json\/wp\/v2\/pages\/443\/revisions\/5524"}],"up":[{"embeddable":true,"href":"https:\/\/marhythe-systems.de\/en\/wp-json\/wp\/v2\/pages\/10"}],"wp:attachment":[{"href":"https:\/\/marhythe-systems.de\/en\/wp-json\/wp\/v2\/media?parent=443"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}