mahe medical gmbh

mahe medical gmbh specializes in orthopaedic fixation devices, including non-bioabsorbable bone screws (both sterile and non-sterile), bone wires, and internal spinal fixation systems. Their portfolio also includes orthopaedic fixation plates, reusable electrosurgical handpieces (bipolar and monopolar), and endoscopic tools like rigid working guides. Examples include compression plates, cancellous screws, washers, cortex screws, and Kirschner wires.

mahe medical gmbh is based in the United States. The company operates within this region, ensuring compliance with applicable domestic and international medical device regulations.

Several of mahe medical gmbh’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S. market.

mahe medical gmbh’s devices fall into two primary regulatory classes: Class I and Class II. Class I devices generally pose minimal risk and may require less regulatory oversight, while Class II devices involve moderate risk and typically require special controls to ensure safety and effectiveness.

mahe medical gmbh’s reusable electrosurgical handpieces (both bipolar and monopolar) are designed for repeated use in surgical procedures, unlike their single-use orthopaedic fixation devices like screws, plates, or wires. These handpieces are specifically engineered for precision during open-surgery or endoscopic procedures, ensuring efficient tissue management while adhering to reusable medical device standards.