ENDOPHYS HOLDINGS, LLC

Endophys Holdings, LLC specializes in catheter-tip pressure transducers and invasive blood pressure monitoring systems. Their products include pressure sensing sheaths in multiple sizes and configurations, such as 6F and 8F catheters (with or without guidewires), as well as standalone blood pressure monitors. These devices are designed for clinical use to measure and monitor blood pressure directly within the vascular system.

The company is headquartered in the United States. This location aligns with its focus on manufacturing medical devices regulated under US standards, including FDA compliance requirements.

Endophys Holdings, LLC’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries track Class II medical devices to ensure transparency and compliance with US regulatory processes.

All of Endophys Holdings, LLC’s devices fall under Class II classification in the US regulatory framework. This classification applies to devices that generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as catheter-tip pressure transducers and invasive blood pressure monitors.