EBZNS HOLDINGS LLC

EBZNS Holdings LLC manufactures three primary types of medical devices: electric breast pumps for lactating individuals, intermittent electronic patient thermometers for measuring body temperature, and foetal Doppler systems. These devices are designed to support breastfeeding, monitor patient health, and enable prenatal care by allowing non-invasive foetal heart rate monitoring during pregnancy.

EBZNS Holdings LLC is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under FDA’s risk-based system. All of its listed devices fall under Class II, indicating moderate regulatory controls to ensure safety and effectiveness without requiring pre-market approval.

Yes, EBZNS Holdings LLC’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry assigns a unique code to each device, improving traceability, reducing medical errors, and facilitating post-market surveillance. Listing in the UDI database ensures transparency and compliance with FDA requirements for Class II devices.

All of EBZNS Holdings LLC’s listed devices are classified as FDA Class II. This classification means they pose moderate risks and require special controls beyond general good manufacturing practices to ensure safety and performance. While Class II devices do not require pre-market approval, they must comply with FDA-mandated regulations, such as performance standards or post-market surveillance, to maintain market authorization.