Quality & Compliance
Certified to internationally recognized quality systems and product standards
The company is certified to the ISO 13485:2016 and EN ISO 13485:2016 medical device quality management system standards (SGS audited, certificate No. CN24/00007437), covering the design, manufacture, and sale of specific protein analyzers, coagulation analyzers, sample processing products, and multiple categories of in-vitro diagnostic reagent kits, and holds CE certification and the TÜV SÜD recognition mark.
The company holds the certifications listed above. For intellectual-property and anti-counterfeiting reasons, certificate copies are not published here; full certificates and product registration documents can be provided to qualified partners at the appropriate stage of cooperation. The SGS certificate (No. CN24/00007437) is independently verifiable in the SGS online database.