{"id":9832,"date":"2025-01-24T08:30:25","date_gmt":"2025-01-24T06:30:25","guid":{"rendered":"https:\/\/uat.safelaser.hu\/medical-device-certification\/"},"modified":"2025-07-16T17:24:27","modified_gmt":"2025-07-16T17:24:27","slug":"medical-device-certification","status":"publish","type":"page","link":"https:\/\/safelaser.hu\/en\/medical-device-certification\/","title":{"rendered":"Medical Device Certification"},"content":{"rendered":"\t\t
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Our medical soft lasers are classified as Class IIa medical devices in accordance with Hungarian Regulation 4\/2009. (III.17.) <\/strong>of the Ministry of Health (E\u00fcM).<\/p>

Our company operates a quality management system compliant with the MSZ EN ISO 13485:2016 standard and the quality requirements set forth in the Hungarian Regulation 4\/2009. (III.17.) E\u00fcM. <\/p>

This standard defines the quality requirements for the following processes related to medical devices:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t

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      The certification ensures that the user receives a safe, effective device of controlled quality, supported by professional servicing.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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      Only CE-marked medical devices may be placed on the market in the European Union.<\/p>

      EC Certificate Number: 144783-18-09-05<\/p>

      Quality Management System Certificate Number: 145223-24-07-08<\/p>

      Notified Body: CE Certiso CE Certiso Orvos- \u00e9s K\u00f3rh\u00e1ztechnikai Ellen\u0151rz\u0151 \u00e9s Tan\u00fas\u00edt\u00f3 Kft. (NB 2409) <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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      Our medical soft lasers are classified as Class IIa medical devices in accordance with Hungarian Regulation 4\/2009. (III.17.) of the Ministry of Health (E\u00fcM). Our company operates a quality management system compliant with the MSZ EN ISO 13485:2016 standard and the quality requirements set forth in the Hungarian Regulation 4\/2009. (III.17.) E\u00fcM. This standard defines […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-9832","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/safelaser.hu\/en\/wp-json\/wp\/v2\/pages\/9832","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/safelaser.hu\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/safelaser.hu\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/safelaser.hu\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/safelaser.hu\/en\/wp-json\/wp\/v2\/comments?post=9832"}],"version-history":[{"count":2,"href":"https:\/\/safelaser.hu\/en\/wp-json\/wp\/v2\/pages\/9832\/revisions"}],"predecessor-version":[{"id":24644,"href":"https:\/\/safelaser.hu\/en\/wp-json\/wp\/v2\/pages\/9832\/revisions\/24644"}],"wp:attachment":[{"href":"https:\/\/safelaser.hu\/en\/wp-json\/wp\/v2\/media?parent=9832"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}