POPS! DIABETES CARE, INC.

POPS! Diabetes Care, Inc. specializes in home-use glucose analyser in vitro diagnostic (IVD) devices. These devices are designed for individual use to measure blood glucose levels outside of clinical settings, such as at home. Their primary product, the POPS! one Blood Glucose Monitoring System, falls under this category.

POPS! Diabetes Care, Inc. is based in the United States. This location is relevant for understanding the regulatory framework governing their devices, as it influences compliance requirements and market authorization processes.

POPS! Diabetes Care, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.

POPS! Diabetes Care, Inc.’s glucose analyser devices are classified as Class II under FDA regulations. This classification is based on the level of risk associated with the device, where Class II devices generally pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.