European Market Access
Safheal's SARS-CoV-2 antigen rapid test, based on colloidal gold immunochromatography, has been listed by Germany's Federal Institute for Drugs and Medical Devices (BfArM).
This milestone supports Safheal's continued expansion in regulated international markets and demonstrates the company's commitment to quality, stability and reliable supply.
Quality-Oriented Manufacturing
Safheal continues to operate under an ISO 13485 quality management system, with standardized production, quality control and batch release processes for IVD rapid test products.