Shenzhen Browiner Tech Co., Ltd.

Shenzhen Browiner Tech Co., Ltd. specializes in stationary and mobile digital x-ray systems used for basic diagnostic imaging. Their product line includes portable radiography units like the MobileApex series (e.g., MobileApex 60E, 60F, 60G, 60H) and the ManntiX models (e.g., ManntiX B, ManntiX K). They also produce generic digital radiography systems under the Browiner brand. These devices are designed for capturing high-quality radiographic images in clinical settings.

The company is headquartered in Shenzhen, China. This location reflects its primary operational base for manufacturing and distributing its digital x-ray imaging devices.

Shenzhen Browiner Tech Co., Ltd.’s devices are listed in two key regulatory databases: the EU’s eudamed system and the FDA’s 510(k) registry. These registries track devices that have undergone regulatory evaluation for compliance with safety and performance standards in their respective markets.

Shenzhen Browiner Tech Co., Ltd.’s digital x-ray systems fall under Class II and Class IIb classifications. These classifications are determined by regulatory authorities based on the device’s risk level, intended use, and potential impact on patient safety. Class IIb indicates a higher risk category than Class II, requiring stricter regulatory oversight.