New Industries Bio-Medicine secures key EU certification for diagnostic kits

Shenzhen New Industries Biomedical Engineering Co., Ltd. announced that its Anti-HBc (CLIA) diagnostic kits, used for the auxiliary diagnosis of hepatitis B virus infection and blood screening, have received IVDR CE certification. This certification, issued by the EU notified body TÜV SÜD, is for the highest risk category, Class D, under the In Vitro Diagnostic Regulation (IVDR, EU 2017/746). The certificates are valid until December 14, 2030, and November 26, 2030, respectively.

This recent approval brings the company's total IVDR CE certified products to 212 chemical luminescence immunoassay reagents and 67 biochemical reagents. The IVDR supersedes the previous In Vitro Diagnostic Medical Devices Directive, imposing stricter requirements for products entering the EU market.

The company states that this certification is a necessary condition for its products to enter the EU market, which is expected to enhance its overall competitiveness and positively impact future operations. However, actual sales performance remains subject to market promotion efforts, and the company cannot currently predict the impact on its future financial results, advising investors to be aware of potential risks.