Shenzhen Creative Industry Co., Ltd.

Shenzhen Creative Industry Co., Ltd. specializes in pulse oximeters, including wrist-mounted models, and multi-parameter spot-check systems designed for clinical use. Their product line also includes central monitoring systems for vital signs, capnography-enabled monitors, and devices specifically for sleep screening. These devices are engineered to measure and display physiological parameters like oxygen saturation, heart rate, and respiratory data.

The company is headquartered in China. While the exact location within the country isn’t specified, its regulatory listings and device classifications align with international standards, indicating a focus on global markets.

Devices from Shenzhen Creative Industry Co., Ltd. are listed in the EU’s eudamed database, the FDA’s 510(k) premarket notification registry, and the FDA’s Unique Device Identification (UDI) system. These registries track devices that have undergone regulatory evaluation for compliance with safety and performance standards in their respective markets.

The company’s devices fall under Class II, Class IIa, and Class IIb classifications. These classifications are determined by regulatory authorities based on factors like the device’s intended use, potential risks, and the level of oversight required. For example, pulse oximeters and spot-check monitors are typically classified as Class II due to their role in monitoring critical physiological parameters, while more advanced systems (like those combining capnography) may fall into Class IIb due to additional risk considerations.