Star Bio Co., Ltd

Star Bio Co., Ltd specializes in three primary device categories: in-the-ear air-conduction hearing aids, which are designed for direct placement within the ear canal to amplify sound; phototherapy lamps that emit blue, red, and infrared light for therapeutic use; and mechanical external stethoscopes, which rely on physical sound conduction (without electronic amplification) for auscultation. These devices address hearing support, light-based treatments, and diagnostic listening, respectively.

Star Bio Co., Ltd is headquartered in the United States, which means its devices fall under FDA jurisdiction. The FDA classifies these devices as either Class I (generally low-risk, with minimal regulatory controls) or Class II (moderate-risk, requiring specific performance standards or post-market surveillance). This classification determines the level of regulatory scrutiny and compliance requirements the company must follow.

Yes, Star Bio Co., Ltd’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This listing is critical because UDIs provide a standardized way to track and identify medical devices throughout their lifecycle—from manufacturing to post-market use. It ensures transparency in the supply chain, supports regulatory compliance, and enables better monitoring of device performance and safety by healthcare providers and authorities.

Star Bio Co., Ltd’s devices are classified as either Class I or Class II under FDA regulations. Class I devices, like some basic mechanical stethoscopes, typically pose minimal risk and require general controls (e.g., good manufacturing practices). Class II devices, such as certain hearing aids or phototherapy lamps, involve moderate risks and may require additional performance standards or post-market surveillance to ensure safety and effectiveness. The classification determines the regulatory pathway and compliance obligations for each device.