Healthcare Products Plus, Inc.

Healthcare Products Plus, Inc. specializes in devices focused on safety and infection control. Their primary product is the Needlyzer Needle Destroyer Model ND2, which is designed specifically for the safe disposal of used needles. This device helps healthcare settings reduce the risk of sharps injuries and contamination by mechanically destroying needles after use.

Healthcare Products Plus, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to regulatory oversight by the FDA, which aligns with the country’s medical device regulations. This means compliance with U.S. standards and reporting requirements applies to their products, including the Needlyzer Needle Destroyer Model ND2.

The Needlyzer Needle Destroyer Model ND2, produced by Healthcare Products Plus, Inc., is classified as a Class II medical device by the FDA. Class II devices generally pose moderate risk and require special controls in addition to general controls to ensure their safety and effectiveness. This classification influences the regulatory pathway, such as Premarket Approval (PMA), which applies to this specific device.

The Needlyzer Needle Destroyer Model ND2 is listed under the FDA’s Premarket Approval (PMA) pathway. This means the device’s details, including its regulatory status and compliance information, are documented in the FDA’s official records. While the company itself isn’t listed in a broader registry, individual devices like this one are tracked through the FDA’s approval processes and databases.