{"id":2837,"date":"2025-11-21T04:05:35","date_gmt":"2025-11-21T03:05:35","guid":{"rendered":"https:\/\/laserrobotarm.com\/?page_id=2837"},"modified":"2026-02-25T15:07:58","modified_gmt":"2026-02-25T14:07:58","slug":"regulatory-information","status":"publish","type":"page","link":"https:\/\/laserrobotarm.com\/en\/regulatory-information\/","title":{"rendered":"Regulatory Information"},"content":{"rendered":"
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1. Introduction<\/span><\/h2> <\/div>\r\n \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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This page provides the official regulatory and legal information for Atlas Medical Technologies GmbH, including manufacturer details, MDR\/CE compliance, documentation, and product-related materials for the Laser Robot Arm.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Company \/ Legal Manufacturer<\/span><\/h2> <\/div>\r\n \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Legal Manufacturer<\/strong>
ATLAS medical Technologies GmbH
Lohrheidestrasse 53
44866 Bochum<\/p>

Registered office: Bochum, Germany<\/p>

Atlas Medical Technologies GmbH is the legal manufacturer of the Laser Robot Arm medical device and is responsible for compliance with applicable European regulations, including the Medical Device Regulation (EU) 2017\/745.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Regulatory Status<\/span><\/h2> <\/div>\r\n \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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CE Marking<\/strong>
The Laser Robot Arm is a CE-marked medical device.

Classification<\/strong>
\u2022 Medical Device Classification: Class I<\/strong> (under MDR)
\u2022 Intended Purpose: Device providing visual support and orientation<\/strong> during CT- and CBCT-guided workflows.

MDR Compliance<\/strong>
Atlas Medical Technologies GmbH ensures full compliance with the Medical Device Regulation (EU) 2017\/745, including technical documentation, safety, performance requirements, and post-market surveillance obligations.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Documentation & Downloads<\/span><\/h2> <\/div>\r\n \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\tThe following documents are available to healthcare professionals and regulatory authorities:\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\r\n Declaration of Conformity (PDF)<\/span><\/a> <\/div>\r\n \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\r\n Laser Robot Arm Brochure (PDF)<\/span><\/a> <\/div>\r\n \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\r\n Instructions for Use (IFU) (PDF)<\/span><\/a> <\/div>\r\n \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Contact & Legal Notice<\/span><\/h2> <\/div>\r\n \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Regulatory Contact<\/strong>
info@atlas4d.de<\/a><\/p>

Legal Notice<\/a>
Privacy Policy<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

1. Einf\u00fchrung Diese Seite enth\u00e4lt die offiziellen regulatorischen und rechtlichen Informationen zu Atlas Medical Technologies GmbH, einschlie\u00dflich Herstellerangaben, MDR\/CE-Konformit\u00e4t, Dokumentation und produktbezogenen Materialien f\u00fcr den Laser-Roboterarm. Unternehmen \/ Rechtlicher Hersteller Legal ManufacturerATLAS medical Technologies GmbHLohrheidestrasse 5344866 Bochum Sitz: Bochum, Deutschland Atlas Medical Technologies GmbH is the legal manufacturer of the Laser Robot Arm medical device and is responsible for compliance with applicable European regulations, including the Medical Device Regulation (EU) 2017\/745. Regulatorischer Status CE-KennzeichnungDer Laser-Roboterarm ist ein CE-gekennzeichnetes Medizinprodukt. Klassifikation\u2022 […]<\/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":{"_acf_changed":false,"footnotes":""},"class_list":["post-2837","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/laserrobotarm.com\/en\/wp-json\/wp\/v2\/pages\/2837","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/laserrobotarm.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/laserrobotarm.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/laserrobotarm.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/laserrobotarm.com\/en\/wp-json\/wp\/v2\/comments?post=2837"}],"version-history":[{"count":53,"href":"https:\/\/laserrobotarm.com\/en\/wp-json\/wp\/v2\/pages\/2837\/revisions"}],"predecessor-version":[{"id":3169,"href":"https:\/\/laserrobotarm.com\/en\/wp-json\/wp\/v2\/pages\/2837\/revisions\/3169"}],"wp:attachment":[{"href":"https:\/\/laserrobotarm.com\/en\/wp-json\/wp\/v2\/media?parent=2837"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}