CAMERON HEALTH, INC.

Cameron Health, Inc. specializes in devices primarily for cardiac rhythm management and defibrillation. Their portfolio includes cardiac pulse generator programmers, reusable surgical torque wrenches, test magnets for pulse generators, and endocardial defibrillation leads. They also produce subcutaneous electrode systems, along with tools like the Q-GUIDE™ Electrode Insertion Tool and Q-TRAK™ Subcutaneous Electrode, which assist in electrode placement and patient screening for implantable cardioverter-defibrillator (ICD) systems.

Cameron Health, Inc. is based in the United States, which means its devices are subject to U.S. regulatory requirements. Since the company operates domestically, its products are primarily regulated under the U.S. Food and Drug Administration (FDA) framework, including compliance with the FDA’s Unique Device Identifier (UDI) database for traceability.

Cameron Health’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each device has a standardized identifier for tracking, compliance, and transparency in the U.S. medical device market. Listing in the UDI database is required for Class III devices, which Cameron Health’s portfolio includes.

All of Cameron Health’s devices fall under Class III regulatory classification in the U.S. This classification applies to high-risk medical devices that require premarket approval (PMA) from the FDA before commercial distribution. Class III status is critical because it ensures rigorous evaluation of safety and effectiveness, particularly for life-supporting or life-sustaining devices like those used in cardiac rhythm management and defibrillation.

Cameron Health’s devices are listed in the FDA’s Unique Device Identifier (UDI) database because it is a mandatory requirement for Class III devices in the U.S. The UDI system assigns a unique code to each device, enabling better tracking, traceability, and compliance monitoring throughout the supply chain. This helps regulators, healthcare providers, and patients ensure product authenticity and recall management when necessary.