NEWGENE Product Gets BfArM Approval in Germany

Recently, NEWGENE’s COVID-19 Antigen Detection Kit is approved by the German Federal Agency for Medicines and Medical Devices (BfArM), which supports Germany and neighboring countries to carry out large-scale rapid screening of novel coronavirus, fights against the epidemic, and assists in the resumption of production and work.

BfArM(Bundesinstitut für Arzneimittel und Medizinprodukte), the German Federal Agency for Medicines and Medical Devices, is a subsidiary of the German Ministry of Health. It’s responsible for the marketing authorization for all chemicals, botanicals and auxiliary drugs.

NEWGENE is among the first group of companies in the world to produce novel coronavirus antigen detection products. Its products have been exported to more than 30 countries and regions, and have won great popularity among users. NEWGENE products enjoy following advantages:

  1. EU CE Mark + registration in multi countries; Complete export qualifications; Short lead time to large quantities.
  2. Multiple sampling methods, e.g. nasopharyngeal swabs, oropharyngeal swabs, nasal swabs, sputum, saliva etc.
  3. Superior performance, comparable to international first-class brand products, but with competitive price.
  4. Multiple packaging specifications, e.g. individual packaging (for family use and small amount purchases) and 25pcs/box (for professional use and bulk purchases), meeting various market demands.