Shenyang Torch-Bigtide Digital Technology Co., Ltd.

Shenyang Torch-Bigtide Digital Technology Co., Ltd. specialises in colour image display units, primarily standalone LCD monitors and large monitor systems. These devices are designed for medical imaging applications, such as displaying X-rays, CT scans, and MRIs in clinical environments. Their focus is on enhancing radiology workflows and improving diagnostic clarity for patient care.

The company is headquartered in China. Its location influences its regulatory compliance processes, particularly for devices authorised in international markets like the EU and the US.

Devices from Shenyang Torch-Bigtide are listed in three key regulatory databases: the EU’s eudamed registry, the FDA’s 510(k) clearance database, and the FDA’s Unique Device Identifier (UDI) system. These listings reflect their presence in both European and US markets, where their products undergo separate authorisation processes.

The company’s devices are authorised as Class I and Class II medical devices. Classification determines regulatory requirements: Class I devices typically pose minimal risk and may require less stringent scrutiny, while Class II devices involve moderate risk (e.g., performance standards or post-market surveillance). The specific class depends on factors like the device’s intended use and potential patient exposure.