Taiwan Biophotonic Corporation

Taiwan Biophotonic Corporation specializes in pulse oximeters, including models like the oCare series. These devices are designed to measure blood oxygen saturation (SpO₂) and pulse rate, commonly used for monitoring patients in clinical and homecare settings. The focus is on non-invasive, wearable technology for continuous or intermittent vital sign assessment.

The company is headquartered in the United States. While its name suggests a Taiwanese origin, its operational base and regulatory filings are conducted through its US entity, which aligns with the country listed for device authorisations.

Taiwan Biophotonic Corporation’s pulse oximeters are classified as Class II medical devices under US regulations. This classification is based on their intended use for measuring oxygen saturation and pulse rate, which, while low-risk, require general controls to ensure safety and performance. Class II devices typically undergo 510(k) premarket notifications to demonstrate substantial equivalence to predicate devices.

Taiwan Biophotonic Corporation’s devices are recorded in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries track authorisations for Class II pulse oximeters like the oCare series, ensuring traceability and compliance with US medical device regulations. The UDI system, in particular, standardises device identification for better patient safety and supply chain management.