SugenTech's COVID-19 Antigen Rapid Test Kit Approved by German Federal Ministry of Health: "Launching Sales in Germany"

[Asia Economy Reporter Yoo Hyun-seok] SuzenTech announced on the 21st that its rapid antigen diagnostic kit for COVID-19 has successfully obtained approval from the German Federal Institute for Drugs and Medical Devices, and it will begin supplying the product primarily in the German region.

This approval was achieved through 'Diasys,' a well-known German diagnostic device company, which handled the registration with the German Federal Institute for Drugs and Medical Devices, and Diasys will also be responsible for product supply.

A SuzenTech official stated, "Since supply in the European region requires certification from each country, SuzenTech proceeded with obtaining the German certification in addition to the European CE certification for the rapid antigen diagnostic kit. Because we received approval from the relatively stringent German Federal Institute for Drugs and Medical Devices, we expect smooth market entry in other European regions through individual certifications." He added, "Diasys already has a network for distributing diagnostic kits, enabling immediate export through product supply."

SuzenTech's COVID-19 rapid antigen diagnostic kit, 'SGTi-flex COVID-19 Ag,' is a kit that tests for COVID-19 infection using nasopharyngeal swab specimens such as nasal mucus, similar to molecular diagnostic (PCR) methods.

When a specimen is dropped onto the kit, the infection status can be visually read within 20 to 30 minutes, like a pregnancy test, allowing suspected patients to be classified immediately at the testing site. It can be analyzed using only the kit without expensive testing equipment or facilities, serving as an alternative to molecular diagnostics.

SuzenTech's COVID-19 rapid antigen diagnostic kit obtained export approval from the Korean Ministry of Food and Drug Safety and European CE certification, with exports starting in October. Exports are expanding as product approvals are obtained in various countries across Europe, Asia, and South America, and the emergency use authorization process with the U.S. FDA is also underway.

This content was produced with the assistance of AI translation services.