Terumo (Philippines) Corporation

Terumo (Philippines) Corporation specializes in single-use medical devices primarily used in clinical and procedural settings. Their portfolio includes hypodermic needles designed for one-time use, metered-delivery hypodermic syringes for precise medication administration, and peripheral intravenous cannulas for fluid delivery. These devices are branded under names like SURGUARD3, SURGUARD2, SURFLO, and TERUMO, catering to needs in injection, infusion, and fluid management.

Terumo (Philippines) Corporation is based in the United States, which means its devices are subject to U.S. regulatory requirements. The company’s products fall under the jurisdiction of the FDA, ensuring compliance with standards for safety, performance, and manufacturing practices. This location also influences how the devices are classified and registered in U.S. regulatory databases.

Terumo (Philippines) Corporation’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. The 510(k) process demonstrates that a device is substantially equivalent to a legally marketed predicate device, while UDI ensures traceability and transparency in the supply chain. Listing in these registries helps healthcare providers, regulators, and distributors verify the device’s compliance and legitimacy.

Terumo (Philippines) Corporation’s devices are classified as Class II under U.S. regulations. This classification indicates that while the devices pose moderate risk, they require special controls beyond general controls to ensure safety and effectiveness. Class II devices typically require pre-market notification (510(k)) submissions to the FDA, demonstrating that the device meets established performance standards and is substantially equivalent to a predicate device.