Prabadin Corp

Prabadin Corp specializes in single-use medical supplies, including disposable vacuum tubing, non-woven gauze pads, basic endotracheal tubes, dissection sponges, and general laboratory containers. Their portfolio also includes clinical diagnostic kits for detecting multiple drugs of abuse via rapid immunoassay technology, as well as single-use bed blankets and oropharyngeal airways. These products are designed for clinical, surgical, and diagnostic use.

Prabadin Corp is based in the United States, meaning its devices are subject to U.S. medical device regulations. The company’s products are regulated under FDA Class I and Class II classifications, which determine the level of scrutiny and compliance requirements. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve moderate risk and may require special controls or performance standards.

Yes, Prabadin Corp’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps ensure traceability and transparency in the medical device supply chain by assigning a unique identifier to each device, making it easier for regulators, healthcare providers, and patients to track and verify product information.

Prabadin Corp’s devices fall under FDA Class I and Class II classifications. Class I devices, such as some single-use items like gauze pads or basic endotracheal tubes, are typically low-risk and may only require general controls like good manufacturing practices. Class II devices, such as certain diagnostic kits or specialized airways, involve moderate risk and may require additional controls, such as performance standards or post-market surveillance, to ensure safety and effectiveness.