HeimBiotek's COVID-19 Diagnostic Kit Receives CE Certification in Europe
HeimBiotek has received CE certification for its COVID-19 diagnostic kit, paving the way for exports to Europe. On the 23rd, HeimBiotek announced that it obtained the CE certification following the manufacturing approval for in vitro diagnostic medical devices for COVID-19. HeimBiotek is currently in contact with several buyers for export to the European region. A company representative stated, “Inquiries for European distribution of our COVID-19 diagnostic kit are ongoing, and we plan to finalize distribution agreements soon to commence exports.” HeimBiotek is also seeking FDA approval for its COVID-19 diagnostic kit in the United States. The representative added, “We expect to receive FDA approval soon and are discussing export plans for the North American market.”
The certified COVID-19 diagnostic kit uses the RT-PCR method, allowing for the confirmation of COVID-19 infection within two hours, enabling rapid large-scale testing. The representative further noted, “Inquiries about the diagnostic kit have surged, and with the approval from the Ministry of Food and Drug Safety and this certification, we expect to boost our export efforts significantly.”
This content is partially excerpted from a news article.