Tec Com Medizintechnik GmbH

Tec Com Medizintechnik GmbH specializes in external circulating-fluid core temperature regulation systems, specifically control units designed for heating and cooling. These devices are engineered to maintain precise thermal control during medical procedures, such as hypothermia or normothermia therapy, ensuring stable core body temperature management.

The company is based in the United States. Its operations align with the regulatory standards and requirements applicable to medical devices within that jurisdiction.

Tec Com Medizintechnik 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 United States, ensuring transparency and traceability.

The company’s devices fall under the FDA’s Class II classification. This classification is assigned based on the level of risk associated with the device, where Class II devices generally pose moderate risk and require special controls to ensure safety and effectiveness.