Autobio Biochemistry Co., Ltd

Autobio Biochemistry Co., Ltd specializes in automated clinical chemistry analyzers, such as the AutoChem series. These devices are designed for laboratory testing and include systems for measuring biomarkers like β2-microglobulin (β2-MG), glucose (GLU), and lactate dehydrogenase (HBDH). The company also produces calibrators and control materials, which are essential for ensuring accuracy and consistency in diagnostic testing workflows.

The company is headquartered in China. This location reflects its operational base for manufacturing, research, and regulatory compliance related to its in vitro diagnostic medical devices.

Yes, some of Autobio Biochemistry Co., Ltd’s devices are included in the EU’s eudamed registry. This registry tracks in vitro diagnostic medical devices authorized for use within the European Economic Area, ensuring transparency and traceability for regulatory oversight.

Autobio Biochemistry Co., Ltd’s devices fall under EU classification categories Class A, B, and C. The classification depends on factors like the intended use, risk level, and potential health impact of the device. For example, calibrators and controls may be classified as Class A due to lower risk, while certain analyzers measuring critical biomarkers like β2-MG could fall into higher risk classes like B or C.