Success Stories

global growth partner to MedTech companies

Breaking news! Pure Global has helped Chinese enterprises obtain the registration certificate for Monkeypox detection in the EU!

This article introduces how Pure Global , as the world's first SaaS+Data cross-border medical device CRO enterprise, has helped many domestic companies complete overseas registration of monkeypox virus detection and successfully launched monkeypox virus PCR detection kits in 27 EU member states, providing full-process consulting services and one-stop solutions for Chinese companies to achieve global market compliance.

2022-05-25

Success in Certification｜Pure Global Helps Hebo BioTech Obtain CE Self-Test Certification!

The article also introduces Hebo Bio's self-developed COVID-19 antigen self-test product, which has obtained the CE 2934 certificate from the EU notified body. This product uses a double antibody sandwich method and can detect results in 15 minutes using a nasal swab testing method. It provides auxiliary diagnosis for COVID-19 infections and can be used for personal and home self-testing. The cooperation between Hebo Bio and Pure Global has provided comprehensive one-stop services, successfully obtaining CE certification and providing valuable time for expanding overseas markets.

2022-05-24

Successful Collaboration | Pure Global Helps ShengXiang Biotech Obtain Three CE List A Certifications, the Highest EU Certification!

Shengxiang Biotech's self-developed three blood-borne infection detection kits have obtained EU CE certification, which is one of the highest levels of certification in the global medical device certification field. Shengxiang Biotech's three products use magnetic bead nucleic acid extraction technology and PCR amplification technology to quantitatively detect hepatitis B, hepatitis C, and HIV in human blood. This certification will help Shengxiang Biotech expand into the European market and achieve better sales performance.

2022-05-23

Pure Global assists Weimi Biotech in obtaining CE 2934 self-test certification!

this article introduces how Micron Biomedical has successfully obtained EU CE certification for its COVID-19 antigen self-test kit after strict review. The product can freely circulate in the EU, further helping global COVID-19 prevention and control. The article also covers Micron Biomedical's self-developed in vitro diagnostic technology and products covering multiple disease diagnosis directions. At the same time, Pure Global also provides one-stop solutions for medical device certification, including regulatory consulting, overseas clinical trials, etc., helping clients' products achieve compliance and enter the global market smoothly.

2022-05-22

Successful Cooperation | Pure Global assists Ruitu Biotech in obtaining EU CE certification for their antigen self-test product!

This article introduces the successful acquisition of CE certification by Shenzhen Ruitu Biotech's new coronavirus antigen detection kit (colloidal gold method) from the EU Notified Body, allowing it to be sold in EU member states. This certification is proof that the self-test product belongs to the Self-test category and requires CE certification. Ruitu Biotech's new coronavirus antigen detection kit has high sensitivity and specificity, which can increase the ability to detect cases early. It is easy and fast to operate, without the need for professionals or equipment, and can meet daily home testing and large-scale screening, effectively helping the global fight against the pandemic. This also demonstrates the professionalism and efficiency of the Prurify team during the CE application process.

2022-05-21

Pure Global assists Kewei Medical in obtaining CE 1434 self-test certification! A rare certificate is coming!

This article introduces the good news that Kewei Medical's new coronavirus antigen self-test kit (colloidal gold method) has successfully obtained EU CE certification. Pure Global provides Kewei Medical with one-stop services, including application acceptance and clinical trials. The acceptance of CE certification requires strict technical reviews and testing, and the issuance time of the certificate is affected by multiple factors such as clinical schedules and technical document reviews. This certification has far-reaching significance for Kewei Medical to explore international markets. Its products can be sold in 27 EU member states and countries that recognize EU CE certification. As a professional and efficient consulting firm, the Pure Global team has always maintained close cooperation with multiple EU Notified Bodies. This CE 1434 certificate issued by PCBC is a very rare certificate in China in recent times. More certificates are expected to come, stay tuned!

2022-05-20

Success Story | Pure Global assists Hangzhou Shijia Saliva Antigen Self-Test Product to Obtain EU CE Certification!

Hangzhou Shijia's new coronavirus antigen detection kit (saliva) has successfully obtained EU CE certification and can be sold. This product uses saliva samples and can quickly detect coronavirus infection within 20 minutes. It can be used as a rapid screening method for COVID-19 suspected cases and as a confirmation method for discharged patients' nucleic acid tests. This certification is a certificate that meets IVDR requirements issued by Notified Bodies after strict technical reviews and testing, fully verifying the safety and clinical performance of the product. As a global medical device certification enterprise, Pure Global provides one-stop consulting services to help clients successfully pass CE certification and meet the challenges of the IVDR era.

2022-05-16

Good news: Zero delay in three days! PRIMER supports Xinyi Biotech's COVID-19 antigen self-test product to obtain CE certification from the EU!

This article introduces the experience of Pure Global assisting Beijing New Yi Bio's independent research and development of new coronavirus antigen self-test products to obtain EU Notified Body certification, explaining the rigorous application process of CE certification and the full-process services provided by the Pure Global team. At the same time, it also mentioned the efforts and advantages of the Pure Global team in assisting domestic clients to successfully pass CE certification under the new IVDR regulations, and looks forward to more high-quality Chinese products going global.

2022-04-24

The CE self-testing certificate is here! Pure Global assists and supports HeXin Health to obtain the EU CE 1434 certificate!

This article introduces the successful assistance of Pure Global in obtaining IVDD CE 1434 certification from the EU Notified Body for Hexin Health's new coronavirus antigen detection kit (colloidal gold method), which can be sold in 27 EU member states and other countries that recognize EU CE certification. This certification proves that its research and development and production capabilities are reliable, and also demonstrates the professional strength and efficiency of the Pure Global team during the CE application process. It provides comprehensive services from application acceptance to clinical trials for domestic manufacturers to penetrate overseas markets with high-quality products.

2022-04-15