AndyForce Registers Four COVID-19 Immunity and Molecular Diagnostic Kits with Germany's DIMDI

[Asia Economy Reporter Park Hyungsoo] AndyForce announced on the 7th that it has completed registration with the German Institute of Medical Documentation and Information (DIMDI) for four types of COVID-19 immune and molecular (PCR) diagnostic kits.

AndyForce explained that its immune diagnostic kits, including the COVID-19 antigen (ND COVID-19 Ag Test), antibody (ND COVID-19 IgG/IgM), molecular diagnostic (ND COVID-19 Detection Kit) kits, and the COVID-19 and influenza simultaneous diagnostic PCR (ND COVID-19 Flu Combo Kit) kit, have been confirmed registered with Germany's DIMDI.

DIMDI is a medical product information system that requires the registration of responsible party information when distributing in vitro diagnostic medical devices in the German market. In European countries with high barriers to entry for medical device markets, Germany's DIMDI registration is required.

Clinical data such as the sensitivity (probability of correctly identifying confirmed positive cases) and specificity (probability of correctly identifying confirmed negative cases) of the diagnostic kits were submitted to the German health authorities for review and passed the standards.

Starting with the European certification (CE) for PCR and COVID-19 and influenza simultaneous diagnostic kits last year, AndyForce obtained CE certification in April this year for a saliva-based COVID-19 rapid antigen diagnostic kit.

With DIMDI registration, AndyForce expects to expand its export scope to Germany and other European countries, anticipating smooth sales growth of related products.

An AndyForce representative said, "To distribute products locally in Germany, where the medical device market is well developed in Europe, it is essential to register products with DIMDI. Since we have completed the relatively stringent DIMDI registration, we expect to accelerate our entry into other European regions."