Biosensors Intl. Pte., Ltd.

Biosensors Intl. Pte. , Ltd. specializes in thermodilution catheters, which are used for hemodynamic monitoring. These devices measure blood flow and cardiac output by injecting a cold saline solution and tracking its dilution in the bloodstream, helping clinicians assess heart function during procedures like cardiac catheterization.

The company is headquartered in the United States. While its legal entity is registered as a private limited company in Singapore (Pte. Ltd.), its primary operational and regulatory presence is within the US market.

Biosensors Intl. Pte. , Ltd.’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 to ensure safety and effectiveness, such as pre-market notification (510(k)) submissions to demonstrate substantial equivalence to a legally marketed predicate device.

Biosensors Intl. Pte. , Ltd.’s devices are included in the FDA’s 510(k) registry, a public database of pre-market notifications for Class II medical devices. This registry tracks submissions required to demonstrate that a new device is substantially equivalent to an existing, legally marketed device, ensuring compliance with US regulatory requirements.