global growth partner to MedTech companies
Congratulations to Jinrui Biotech for their rapid antigen testing product being included in the EU HSC RAT Common List!
This article introduces Shenzhen Jinrui Biotechnology Co., Ltd.'s COVID-19 antigen detection test kit (colloidal gold method), which has been approved to enter the EU's rapid antigen detection test list. The product has passed EU CE certification and FDA certification. Furthermore, Prudence Certification provides professional certification services, offering one-stop export certification, testing, customs clearance logistics, channel docking, data querying, and other services for clients, providing comprehensive support and solutions for medical device enterprises.2021-07-16
BaiBo Biology: Pioneering Excellence in IVD with FDA and EU Certifications
Recently, an IVD enterprise from Shandong successfully obtained the US FDA's Emergency Use Authorization (EUA) and the EU MDD CE certificate, as well as the ISO13485 quality system certificate from the NB announcement agency Intertek Tianxiang. Their virus sampling tubes, sterile swabs, and COVID-19 antigen test kits have also been listed on the US FDA EUA white list, the EU CE certificate, and the German BfArM white list, laying a solid foundation for market access.2021-05-05
Can you really get a top-notch CE Module B+C2 in just ten days?
This article introduces the CE certification of medical devices, including the standards and procedures for CE certification, as well as the things to be aware of. At the same time, we provide information on how to apply for BSI certification and register in the EU market.2020-08-05
It only takes three days to obtain FDA EUA authorization! This company has broken the record!
Medical device certification is an important means of ensuring product quality and safety, and certifications such as the US FDA and EU CE have become internationally recognized standards. Pure Global provides certification services, including 510K, NIOSH, ASTM F2100, etc., to help manufacturers obtain broader recognition and sales opportunities in the international market. In addition, Pure Global 's global medical device selection platform can help buyers and sellers quickly connect with high-quality supplies, solving problems such as anonymous phone calls and false qualifications during the epidemic. We are committed to helping domestic production enterprises access the international market and promoting industry development!2020-07-22