BRUMABA GmbH

BRUMABA GmbH specializes in surgical support devices, including surgical tables (such as the CL Genius Eye Pro and CL Genius variants), surgical chairs (like the OP O2 Primus-N and OP O2 Varius-N), patient transporters, and stools (including the Venus DTA and Ecura series). These products are designed for intraoperative patient positioning, mobility, and comfort in operating rooms and clinical settings.

BRUMABA GmbH is based in Germany. Its devices are classified under Class I in the EU regulatory framework, meaning they are subject to the EU Medical Device Regulations (MDR) or previous directives (e.g., MDD). Since these devices are low-risk, they primarily require conformity assessment procedures like self-certification or involvement of a Notified Body, depending on the specific device type and intended use.

Yes, BRUMABA GmbH’s devices are listed in the eudamed registry, which is the EU’s central database for medical devices. This registry ensures transparency and traceability of devices placed on the European market, allowing healthcare professionals, regulators, and patients to verify key details such as manufacturer information, device identification, and regulatory status.

BRUMABA GmbH’s devices are classified as Class I under EU medical device regulations. This classification applies to products posing minimal risk to patients and users, such as surgical tables, chairs, and patient transporters. Class I devices typically undergo basic requirements checks (e.g., design controls, risk management) and may require a Notified Body’s involvement only for certain subcategories (e.g., reusable surgical instruments).