global growth partner to MedTech companies
Wow! A Chinese IVD company obtained CE certification within 10 days, there must be some experts behind this achievement!
This article introduces CeCert, a newly added public announcement agency under the EU, which has become an NB agency for issuing CE certificates under the IVDD regulation and is widely favored by domestic manufacturers. Meanwhile, the team at Pure Global has helped three new COVID-19 antigen test kits from domestic manufacturers obtain CE certification acceptance letters from this agency in a short period of time, as the time is running out for the opportunity to obtain CE certificates. The article also introduces CE 1434 self-assessment certification, as well as Pure Global as a one-stop service provider for the entire process, helping domestic manufacturers achieve the level of technical document writing in Europe and the ability to communicate and provide service support in China. Finally, the article reminds manufacturers to seize the last five months of the opportunity to obtain CE certification before the implementation of the new IVDD regulations, while the public announcement agency can still handle and accept cases.2023-03-27
Pure Global | Only 3 Days! Helping Clients Complete Swiss Registration and Filing
This article introduces the broad market prospects of Swiss registered medical devices sold in Switzerland. The professional team at Pure Global has helped clients complete registration in a short period of time and opened up overseas markets. The article also mentions important content such as EU certification, end-to-end consulting, and clinical trials, providing market strategies and global compliance support for medical device companies.2022-12-21
Perfect Ending | Pure Global Helps Beijing Kewei Clinical Diagnostic Reagents Co., Ltd. Obtain CE 1434 Certificate!
This article introduces how Pure Global successfully helped Beijing Covawin Biotech's COVID-19 antigen self-test kit pass the CE 1434 medical device certification, which uses advanced lateral flow immunochromatography technology, superior performance, and has obtained access qualifications to the European market, contributing Chinese strength to global epidemic prevention and control. Pure Global provides end-to-end consulting services and professional service teams to help Chinese brands expand in the international market.2022-06-04
Successful Cooperation | Pure Global Team Helps Jiangsu Yino Biotechnology's Antigen Self-Test Product Obtain EU CE Certification
This article introduces that Jiangsu Innovita Biological Technology Co., Ltd.'s self-developed COVID-19 antigen self-test product has obtained the IVDD CE 2934 certificate issued by the EU public announcement agency. The product uses colloidal gold method, collects samples with nasal swabs, can quickly produce results within 10 minutes, and has high sensitivity and specificity, as well as simple operation. Through this cooperation, Pure Global provides a one-stop comprehensive professional service to help Innovita successfully enter the European market.2022-06-02
Success Story | Pure Global Assists Pumen Technology in Obtaining EU CE Self-Test Certification!
This article introduces how Shenzhen Pumier Technology Co., Ltd.'s self-developed COVID-19 antigen detection kit (colloidal gold immunochromatography method) obtained EU self-test CE certification in the IVDD regulatory era. The product has the advantages of simple operation, quickness, can be operated individually, does not require special equipment, and is easy to observe. It is a new coronavirus detection solution suitable for individual, family, and community screening. At the same time, this certification also helps Pumier Technology further deepen its international business strategy and grow into a globally respected excellent medical device supplier.2022-05-31
Success Story | Pure Global team assists Jiangsu Baoshilin Medical in obtaining EU CE certification
This article introduces that Jiangsu Baodi Forest Medical Technology Co., Ltd.'s COVID-19 antigen detection test kit has obtained the IVDD CE 2934 certificate through EU CE certification and has successfully entered the 27 member states of the EU and countries that recognize EU CE certification for sales. The self-test product from Baodi Forest Medical is simple to operate, convenient to test, and the accuracy of the results is as high as 97.35%, with a specificity of 100%, which helps with early triage and rapid management, effectively assisting global COVID-19 testing.2022-05-29
Success Story | Pure Global assists Dynamiker in obtaining CE 2934 self-test certification!
This article introduces that DynaBio's self-developed COVID-19 rapid antigen detection test self-test kit (Dynamiker SARS-CoV-2 Ag Rapid Test) has successfully obtained EU CE 2934 certification. This is also an important cooperation for Pure Global 's services, and the Pure Global team provided "one-stop" high-quality services from application acceptance to clinical trials to help DynaBio expand its sales share in the global market. DynaBio is a comprehensive bio-pharmaceutical national high-tech enterprise, dedicated not only to the research and development of early rapid joint diagnosis products for invasive fungal diseases and other pathogenic microorganisms, but also to the molecular diagnosis of COVID-19 testing, contributing Chinese strength to global epidemic prevention and control.2022-05-28
Ten Certificates Issued! Pure Global Certificates Assists Xinchan Industry Bio to Win 10 CE List A Certificates with the Highest Recognition
This article introduces that New Industry Biotech has obtained CE certification for five chemiluminescent reagent products and corresponding quality control solutions in the EU. These products are used for the diagnosis and testing of hepatitis B virus, which is the second largest cancer inducer in the world, and the testing market is huge. This CE certification makes New Industry Biotech the first domestic chemiluminescent manufacturer to obtain CE List A certification on the three major infectious disease projects of hepatitis B, hepatitis C, and HIV, greatly enhancing the company's position in the global in vitro diagnostic field.2022-05-26
The Second in the World! Following Roche, Shengxiang Becomes the Second Company to Obtain CE List A Certification for Blood Screening with Pure Global 's Help in the European Market
Shengxiang Biotech has obtained global market compliance through EU CE certification. Its self-developed nucleic acid detection kit has successfully obtained CE List A certification, making it the first Chinese blood screening nucleic acid detection kit to receive the highest EU CE certification. The Pure Global service team has assisted Shengxiang in completing medical device certification, providing full-process consulting services for its high-quality Chinese-made products to enter overseas markets.2022-05-25