On July 3, 2024, Jinan Babio Biotechnology Co., Ltd. disclosed the "Indicative Announcement on Passing the ISO13485 International Quality System Certification of TÜV SÜD". The certification scope includes: the design, development, production and sales of rapid in vitro diagnostic test kits, including colloidal gold immunochromatography kits for immunochemistry and infectious disease detection, and in vitro diagnostic consumables for virus sample storage and transportation.
It is reported that Babio Biotech has successfully obtained the ISO 13485 quality system certification issued by Beijing Guoyixi Huaguang Certification Co., Ltd., IntertekTesting Services NA Ltd. ("ITS") and SGS United Kingdom Ltd. ("SGS"). The three institutions jointly provided strong system support for the company's international registration, and this time TÜV SÜD's quality system certification is even more powerful.
Since its establishment in 2003, Jinan Babio Biological Co., Ltd. has been focusing on the research and development, production, sales and service of medical devices and in vitro diagnostic reagents. It is a world-leading R&D and innovative high-tech enterprise that provides in vitro test standards. The company has established a strict quality management system and passed ISO9001 and ISO13485 international quality system certification. It has the most advanced fully automatic production equipment in the world. The workshop is strictly designed according to the standard and reaches the 10,000-level purification standard. At present, Babio now has a wide range of products, covering colloidal gold rapid test kits for humans and pets, dry powder culture medium, virus sampling tubes and swabs, cardiovascular diseases, infectious diseases, drug testing, pregnancy, biochemistry, myocardial testing, laboratory consumables, infusion and blood transfusion and other medical consumables. Many of our products have been sold in more than 100 countries and regions, with competitive and satisfactory products and services.
TÜV SÜD is one of the three major certification bodies in the world, with extremely high authority and influence in the industry; and TÜV SÜD is one of the few notified bodies with IVDR certification qualifications. The passing of ISO 13485 certification demonstrates Babio's continuous improvement and pursuit of excellence in the field of quality system management, proving that the company has reached internationally advanced levels in quality management and safe production. It lays the foundation for BioBio to obtain EU CE certification for in vitro diagnostic products under IVDR regulations, and will help Babio's international business expansion to reach a new level.