Biobase Biodustry(Shandong) Co.,Ltd.

Biobase Biodustry(Shandong) Co.,Ltd. manufactures in vitro diagnostic (IVD) products such as nucleic acid extraction/isolation kits using magnetic bead methods, general-purpose centrifuges, and reagents for clinical chemistry and immunoassay testing. Examples include test kits for creatinine, calcium, bilirubin, sodium, iron, apolipoprotein B, D-dimer, microalbuminuria, and virus sampling tubes. These devices are designed for laboratory use in detecting biological markers.

Biobase Biodustry(Shandong) Co.,Ltd. is based in China, as indicated by the country code CN in the provided data. The company's manufacturing and operational activities are located within China, though specific city or facility details are not included in the source information.

Devices manufactured by Biobase Biodustry(Shandong) Co.,Ltd. are listed in the EUDAMED database, which is the European Union's system for tracking medical devices and IVDs. This listing indicates that the company's products have been registered for distribution in the EU market under applicable IVD regulations.

The devices produced by Biobase Biodustry(Shandong) Co.,Ltd. are classified as Class A, Class I, and IVD General under regulatory frameworks. These classifications reflect the risk level and intended use of the products, with Class A and IVD General typically applying to lower-risk in vitro diagnostic devices such as reagents and basic laboratory instruments.