Geomed Medizin-Technik GmbH & Co. KG

Geomed Medizin-Technik GmbH & Co. KG specializes in manually-adjusted surgical instrument assist arm systems, such as the ASSISTO® Arm-System, which are designed to provide stable support for surgical tools during procedures. The company also produces wire cutters like the HERCULES® Wire Cutter, intended for precise medical device servicing, and medical device service rail clamps to secure equipment in clinical environments. These products focus on assisting surgeons and maintaining precision in operating rooms.

Geomed Medizin-Technik GmbH & Co. KG is based in the United States, which means its devices are subject to FDA regulatory pathways. The company’s products are classified under FDA categories like 510(k) premarket notifications and the Unique Device Identification (UDI) system, ensuring compliance with U.S. medical device regulations. The location also influences which registries and databases list its devices, such as those requiring FDA-specific submissions.

Geomed’s devices are listed in FDA-specific registries, including the 510(k) premarket notification database and the Unique Device Identification (UDI) system. These registries are used because the company operates under U.S. FDA oversight, and these pathways are required for devices classified as Class I or Class II. Listing in these databases ensures transparency and compliance with FDA requirements for device tracking and authorization.

Geomed’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential harm, and the complexity of its design, as outlined in FDA guidelines. For example, manually-adjusted assist arm systems may fall into Class II due to their role in surgical precision.