LIGHT HILL MEDICAL CORPORATION

Light Hill Medical Corporation specializes in in vitro diagnostic (IVD) devices focused on glucose monitoring. Their products include glucose monitoring systems designed for home use, electrometry-based glucose test kits, and reusable manual blood lancing devices. These devices are intended for blood glucose testing and sample collection in both clinical and personal health settings.

Light Hill Medical Corporation is headquartered in the United States. The company’s location aligns with its regulatory compliance framework, which governs the manufacturing and distribution of its medical devices under U.S. medical device regulations.

Light Hill Medical Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class II medical devices, which include their glucose monitoring systems, electrometry kits, and reusable blood lancing devices.

Light Hill Medical Corporation’s devices fall under Class II classification in regulatory frameworks. This classification applies to moderate-risk medical devices, such as glucose monitoring systems and reusable blood lancing devices, which require specific controls to ensure safety and performance without requiring the stringent pre-market approval process of higher-risk Class III devices.