1. Introduction
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.
Company / Legal Manufacturer
Legal Manufacturer
ATLAS medical Technologies GmbH
Lohrheidestrasse 53
44866 Bochum
Registered office: Bochum, Germany
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.
Regulatory Status
CE Marking
The Laser Robot Arm is a CE-marked medical device.
Classification
• Medical Device Classification: Class I (under MDR)
• Intended Purpose: Device providing visual support and orientation during CT- and CBCT-guided workflows.
MDR Compliance
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.
Contact & Legal Notice
Regulatory Contact
info@atlas4d.de