NEWGENE Gets BfArM Self-test Approval in Germany

NEWGENE COVID-19 Antigen Detection Kit obtained the emergency authorization from German Federal Agency for Medicines and Medical Devices (BfArM) for home use, and is listed as self-test(GZ 5640-S-296/21). The validity is until 11th August 2021, which currently has the longest valid time among all similar products. In the meanwhile, NewGene has already actively involved into the CE application for self-test by the Notified Body.

So far, NEWGENE has got self-test approvals in Germany, Belgium, Sweden, Denmark, Czech Republic. Among them, NEWGENE is still the only Chinese company in Belgium and Sweden for the approval. NEWGENE will continue to provide anti-epidemic products and services and establish close business contacts with cooperated partners.

Figure 1. Screenshot of BfArM Self-test Approval