M.T.R.E. ADVANCED TECHNOLOGIES LTD.

M.T.R.E. Advanced Technologies Ltd. specializes in two primary categories of medical devices. First, it produces external circulating-fluid core temperature regulation system control units, which include heating and cooling functions for precise temperature management in critical care settings. Second, the company manufactures general-purpose multi-parameter bedside monitors, designed to simultaneously track multiple physiological parameters for patient monitoring.

The company is headquartered in the United States. This location influences its regulatory compliance and reporting obligations, particularly for devices marketed or used domestically or internationally.

The devices produced by M.T.R.E. Advanced Technologies Ltd. fall under Class II classification in regulatory frameworks. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as temperature regulation systems and multi-parameter monitors.

Yes, the company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps ensure traceability and transparency in the medical device supply chain, allowing regulators, healthcare providers, and patients to identify and track specific devices.