IVD China last week: Hotgen, Sansure, Bioperfectus, URIT and Genrui

Hotgen receives CE IVDR certificate for chemiluminescence immunoassays

Recently, Hotgen Biotech receives its first CE IVDR certificate, issued by British Standards Institution (BSI), one of the most prestigious certification organizations in Europe. The certificate covers 14 key diagnostic indicators in a number of important clinical testing areas such as cardiac, inflammation, hormones and tumor. 

Sansure's TB testing receives CE IVDR certification

Recently, Mycobacterium tuberculosis nucleic acid test kit (PCR-fluorescent probe method) developed by Sansure Biotech has been certified by CE IVDR, and this respiratory product is the first Class C certificate obtained by the company.

Bioperfectus’s 9 products are certified by EU IVDR

Bioperfectus recently obtains CE IVDR certificates for their 9 produces. The company's overseas sales of product categories have been further expanded, the relevant products of the overseas application have been broadened, which for the company's overseas sales and international business expansion.

URIT's products have been certified by both US FDA and EU IVDR

Following the success of URIT's UC-1800 automatic urine analyzer passing the U.S. FDA certification, URIT's urine analysis products and POCT products have gained FDA approval, and the whole line of IVD products have successfully passed the IVDR certification, which signifies that its technological innovation and product quality have reached the international standard.

A number of Genrui's products receive the EU IVDR certification

Recently, Genrui Biotech receives the IVDR CE Class B/C certification of their products, issued by the European Union's notified body, TÜV SÜD, which include a series of triclinic hematology analyzers and a number of specific protein testing reagents.