On the first anniversary of the passing of Mr. Jianjiang Chen, Founder and Chairman of the Company, Atlas Link officially announces the establishment of a new brand series, JIANJIANG®, in recognition of his contribution to the founding, development and direction of the Company.
In memory of Mr. Jianjiang Chen, whose vision continues to guide the development of Atlas Link
The JIANJIANG® brand will focus on high-risk medical devices and in vitro diagnostic products intended for stringent international regulatory pathways, including EU CE-IVDR Class D, U.S. FDA Premarket Approval (PMA), and WHO Prequalification (WHO PQ).
The first planned JIANJIANG® products include a fourth-generation HIV self-test, HCV rapid test and HBsAg POCT rapid test. The Company’s R&D, Quality, Regulatory Affairs and other relevant functions are currently carrying out pre-market preparation activities for these products and receiving professional regulatory and registration guidance. Product development, performance evaluation, risk management and registration preparation are being advanced in accordance with the applicable international market-access requirements.
JIANJIANG® represents more than a new product brand. It carries forward the vision and commitment of the Company's founder. The Company will place device safety and performance at the forefront, with risk management applied throughout the entire product lifecycle, including design and development, verification and validation, manufacturing, pre-market evaluation, post-market surveillance and continual improvement. Through rigorous quality control, performance evidence and risk control, Atlas Link will continue to advance high-risk IVD products toward international markets.