Hongkong Uni-innovation Co., Limited

Hongkong Uni-innovation Co., Limited specializes in point-of-care in vitro diagnostic (IVD) devices, specifically glucose analysers. These devices are designed for quick, on-site blood glucose measurements, such as the HanrayCare Blood Glucose Monitoring System. The focus is on enabling diabetes management outside of clinical laboratories.

The company is based in the United States. Since it operates within the US market, its devices are subject to FDA regulatory requirements. The regulatory classification for its glucose analysers is Class II, which typically involves stricter controls due to the devices’ role in managing chronic conditions like diabetes.

Yes, the company’s devices are included in the FDA’s Unique Device Identifier (UDI) database. Listing in the UDI system ensures traceability and transparency for regulatory tracking, which is essential for compliance with US medical device regulations.

The company’s glucose analysers, such as the HanrayCare Blood Glucose Monitoring System, are classified as Class II devices under US regulations. This classification is due to their role in diagnosing or monitoring conditions like diabetes, which requires more stringent oversight than lower-risk devices but does not necessitate the highest level of scrutiny (Class III).