Samsung Electronics Co., Ltd.

Samsung Electronics Co., Ltd. specializes in mobile applications for electrocardiographic monitoring. These include software tools that allow users to record and analyze heart rhythms via smartphone-based ECG readings, such as the Samsung ECG Monitor Application and variants with irregular heart rhythm notifications. These products focus on self-care monitoring and reporting, leveraging existing smartphone technology to provide accessible cardiac health tracking.

Samsung Electronics Co., Ltd. operates from the United States, which is the primary location for its medical device operations. This geographic presence aligns with regulatory frameworks like the FDA, ensuring compliance with U.S. standards for device classification, reporting, and listing. The company’s U.S. base also facilitates direct engagement with regulatory bodies and healthcare stakeholders in North America.

Samsung’s electrocardiographic monitoring devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical for tracking and identifying medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers, regulators, and patients. Listing in the UDI database is a requirement for Class II devices under FDA regulations.

Samsung’s electrocardiographic monitoring applications are classified as Class II devices by the FDA. This classification is based on the moderate risk associated with these products, which involve interpreting heart rhythm data to detect potential irregularities. Class II devices require special controls beyond general controls to ensure safety and effectiveness, such as performance standards and post-market surveillance.