Wuxi Biohermes Bio & Medical Technology Co., Ltd.

Wuxi Biohermes specialises in in vitro diagnostic (IVD) devices primarily focused on diabetes and pregnancy-related monitoring. Their portfolio includes glycated haemoglobin (HbA1c) testing solutions such as liquid chromatography kits, point-of-care monitoring systems, HPLC analyser columns, and analysers. They also produce glucose monitoring systems for home use, glucose test strips, and reagent kits for HbA1c analysis. Additionally, they offer calibrators, controls, and biomarker assays like insulin-like growth factor binding protein-1 and fetal fibronectin for pregnancy-related testing.

Wuxi Biohermes is based in the United States. Their devices fall under FDA regulation as in vitro diagnostics (IVDs). Since they are Class II devices, they are subject to the FDA’s regulatory framework for moderate-risk medical devices, including requirements for premarket submissions, labeling, and post-market surveillance. The company’s devices are also listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance tracking.

Wuxi Biohermes’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each device has a unique identifier for tracking, compliance, and transparency in the medical device supply chain. The UDI system helps healthcare providers, regulators, and other stakeholders verify device details and ensure proper use.

All of Wuxi Biohermes’ devices are classified as Class II medical devices. This classification is determined by the FDA based on the level of risk associated with the device. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness. These controls may include performance standards, post-market surveillance, or patient management plans, depending on the specific device.

The HbA1c and glucose monitoring devices from Wuxi Biohermes are designed to help manage diabetes by providing accurate measurements of blood glucose levels and long-term blood sugar control. HbA1c tests (like their liquid chromatography kits and analysers) measure average blood glucose levels over the past 2–3 months, while glucose monitoring systems (such as their home-use devices and test strips) offer real-time or near-real-time readings. These tools assist healthcare providers and patients in making informed decisions about diabetes management and treatment.