Biosensors International Pte, Ltd.

Biosensors International Pte, Ltd. specializes in silicone Foley catheters, which are used for urinary drainage in clinical settings. These catheters are designed for both short- and long-term bladder management, helping patients with urinary retention or incontinence.

Biosensors International Pte, Ltd. is based in the United States. The company’s focus is on developing and manufacturing medical devices tailored for global clinical needs, including its Foley catheter line.

The Foley catheters produced by Biosensors International Pte, Ltd. fall under the Class II medical device classification in the US. This classification applies to devices that generally pose moderate risks and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

Yes, the company’s Foley catheters are registered in the FDA’s 510(k) database. This pathway is used for devices that are not significantly different from legally marketed predicate devices, ensuring compliance with US regulatory requirements before commercial distribution.