EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED

EPIC International specializes in devices for fluid administration and infusion therapy. Their portfolio includes elastomeric infusion pump systems for continuous, controlled fluid delivery, intravenous administration bags and bottles for medication or fluids, and accessories like vial/bottle adaptors, Luer connectors, bag access spikes, fluid transfer sets, tubing extensions, and catheter injection ports. These products are designed for single-use in clinical settings to ensure patient safety and regulatory compliance.

EPIC International is based in the United States, which means their devices are developed and manufactured under US regulatory standards. This ensures compliance with FDA requirements for medical devices, including classification, labeling, and post-market surveillance. The US location also facilitates adherence to both domestic and international quality and safety guidelines for infusion and fluid management systems.

EPIC International’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in regulatory compliance and post-market monitoring. Listing in this database is required for Class I and Class II devices, which aligns with the company’s product portfolio.

EPIC International’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential harm, and the body part it interacts with, as outlined in FDA’s regulatory framework.

Listing in the FDA UDI database means each of EPIC International’s devices has a unique identifier that includes a device identifier and a production identifier. This system improves device tracking, reduces medical errors, and supports regulatory oversight by providing clear, standardized information about the device’s manufacturer, model, batch, and expiration. It also aids healthcare providers in verifying product authenticity and compliance with FDA requirements.