Shenzhen New Industries Biomedical Engineering Co., Ltd.

The company specializes in in-vitro diagnostic (IVD) devices, primarily focused on chemiluminescent immunoassay (CLIA) technologies. Their portfolio includes diagnostic kits for measuring free thyroxine (FT4), multiple forms of 25-hydroxy vitamin D, thyroid stimulating hormone (TSH), and total human chorionic gonadotropin (HCG). They also produce standalone immunoassay analysers, such as the MAGLUMI 2000 series, and control materials for HCG testing. These devices are designed for laboratory use to provide quantitative and qualitative results for various health markers.

The company is based in China, specifically in Shenzhen. This location reflects its regional focus on manufacturing and distributing in-vitro diagnostic devices, including chemiluminescent immunoassay systems and related reagents.

The company’s devices are listed in multiple global regulatory databases, including the EU’s EUDAMED system, the FDA’s 510(k) premarket notification registry, and the FDA’s Unique Device Identifier (UDI) database. These registries help track and monitor the devices’ compliance and availability in different markets.

The devices fall under various regulatory classifications depending on their risk level and intended use. They are categorized as IVD General, IVD Annex II List B, and regulatory classes A, I, and II. Classifications like these determine the regulatory scrutiny and requirements for market authorization, ensuring appropriate oversight based on the device’s potential risk to patient health.

The analysers and kits are designed for high-throughput, fully automated chemiluminescent immunoassays in clinical laboratories. They enable accurate detection and quantification of biomarkers such as FT4, 25-hydroxy vitamin D, TSH, and HCG, supporting diagnostics for conditions like thyroid disorders, vitamin D deficiency, and pregnancy-related assessments. The automation and broad test menu make them suitable for high-volume laboratory workflows.