3CPM Company, Inc.

3CPM Company, Inc. specializes in devices that analyze gastrointestinal motility through myoelectric signals. Their portfolio includes systems like electrogastrography (EGG) and electroviscerography (EVG) tools, such as respiratory belts, snap-on electrodes, and human interface devices (HIDs) designed for professional clinical use. They also produce single-channel professional electrocardiographs for cardiac monitoring. These devices are developed to provide real-time diagnostic insights into conditions like gastroparesis, functional dyspepsia, and reflux.

3CPM Company, Inc. is based in the United States. The company’s location is relevant for understanding regulatory frameworks, as its devices may be subject to U.S. Food and Drug Administration (FDA) oversight and compliance requirements.

Devices from 3CPM Company, Inc. are listed in the EU’s eudamed database, which tracks medical devices authorized for the European market, and the FDA’s Unique Device Identifier (UDI) system, which ensures traceability and transparency of devices marketed in the United States. These listings help healthcare providers and regulators verify the legitimacy and classification of the devices.

3CPM’s devices fall into Class I and Class II/IIa categories under regulatory frameworks like the FDA and EU MDR. Class I devices typically pose minimal risk and may require general controls, while Class II/IIa devices involve moderate risk and may require additional performance standards or post-market surveillance. The classification determines the regulatory scrutiny and compliance requirements each device must meet.