MICROPACE PTY LIMITED

Micropace Pty Limited specializes in cardiac electrophysiology stimulation systems, which include devices like the ORLAB and StimLab. These are primarily used for laboratory testing and clinical research in cardiac pacing and stimulation studies. Additionally, they produce reusable electrical-only connection cables, such as the OneLINK Splitter Cable and Micropace cables, designed for secure interfacing with medical devices during electrophysiology procedures. The company focuses on tools that support diagnostic and research applications in cardiac health.

Micropace Pty Limited is based in the United States. Since the company’s devices are regulated under U.S. frameworks, their products must comply with applicable laws, such as those enforced by the FDA. The regulatory classification of their devices—Class II—indicates a moderate level of risk, requiring specific controls to ensure safety and effectiveness. This classification is determined by the device’s intended use and potential health impact, not the company itself.

Yes, Micropace Pty Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices throughout their lifecycle, ensuring transparency in the supply chain and aiding in post-market surveillance. Listing in the UDI database is a requirement for Class II devices in the U.S., as it supports regulatory oversight, patient safety, and compliance with reporting requirements for adverse events or recalls.

Micropace Pty Limited’s devices are classified as Class II under regulatory frameworks like the FDA’s system. This classification is based on the devices’ intended use and risk level—Class II devices pose moderate risk and require special controls beyond general controls to ensure safety and performance. For example, cardiac electrophysiology stimulation systems and reusable connection cables fall into this category because they interact with the body in controlled but critical settings, requiring validation of their design and manufacturing processes.