Wuhan Xurui Biotechnology Co., Ltd.
  • Was established

    2021Year

    Was established
  • Registered capital

    10000Thousand yuan

    Registered capital
  • Building area

    2400m²

    Building area
  • Clean production workshop

    100Thousand level

    Clean production workshop

    • Wuhan Xurui Biotechnology Co., Ltd. was established in 2021 and is a new modern IVD enterprise specializing in the research and development, production, and sales of diagnostic reagents. The company is located in Wuhan Optics Valley International Biomedical Enterprise Accelerator Park, with a building area of 2400 square meters and a registered capital of 10 million yuan. It has abundant human resources and strong technical strength.

    The company designs and constructs clean rooms in accordance with GMP standards, introduces advanced domestic production equipment and inspection instruments, establishes a scientific and comprehensive quality management system based on GMP and ISO13485 standards, and obtains a medical device production license in 2023.

    The company continues to deepen the construction of technology platforms, with three major raw material evaluation and kit development and production platforms, enzyme immunity/luminescence, immunoturbidimetry and colloidal gold/fluorescence chromatography, innovation in the POCT field, covering renal function, cardiovascular, reproductive, digestive metabolism, inflammation and animal disease fields. At the same time, we can provide OEM services such as biochemical turbidity large packaging, colloidal gold plate/fluorescent test strip.

    The company adheres to the quality policy of "quality first, integrity-based, satisfactory service, and continuous improvement", always remembering that "quality is the cornerstone of the company's survival and the reason why customers choose the company". At the same time, it establishes the business philosophy of "customer-centric" and provides customers with high-quality products, services, and solutions.

    Xurui Biotechnology is based in the field of POCT, actively expanding and developing products in the sub fields of kidney function, cardiovascular, reproductive, digestive metabolism, and inflammation, achieving sustainable development with professional characteristics, establishing and improving a quality management system that complies with international GMP standards, and introducing refined production methods to further enhance the company's core competitiveness. It is determined to become a "leader in the POCT field" and better serve the human health cause.

    About Xurui

    CORPORATE CULTURE

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    DEVELOPMENT HISTORY

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    2021
    2022
    2023
    2024
    2025
    2021Year
    On February 8th, Wuhan Xurui Biotechnology Co., Ltd. was established with a registered capital of 10 million yuan.
    2022Year
    The company's new chromatographic diagnostic reagent product development project has obtained the record certificate of fixed assets investment project in Hubei Province. After the project is completed, it will produce 10 million diagnostic reagents annually.
    2023Year
    On May 15th, the company obtained the medical device registration certificate (in vitro diagnostic reagent) for its first product, the Urine Microalbumin Detection Kit (Colloidal Gold Method), with registration certificate number: EXie Zhuzhun 202322404315. The expected use of this product is for in vitro qualitative detection of albumin in human urine samples. On June 13th, the company obtained the Medical Device Production License (EYJX Production License No. 20231238) issued by the Hubei Provincial Drug Administration, with a production scope of Class II, 6840 in vitro diagnostic reagents.
    2024Year
    The development project of the company's chromatographic diagnostic reagent product was successfully completed in January, and the environmental protection passed the expert group acceptance organized by the Emergency Management Bureau of Donghu New Technology Development Zone in Wuhan. On March 25th, the company obtained registration certificates for three medical devices (in vitro diagnostic reagents): D-Dimer detection kit (colloidal gold method) (E-Jiao Zhuzhun 20242404861), cardiac troponin I (cTnI) detection kit (colloidal gold method) (E-Jiao Zhuzhun 20242404860), and insulin-like growth factor binding protein-1 (IGFBP-1) detection kit (colloidal gold method) (E-Jiao Zhuzhun 20242404859). On August 28th, the company obtained the medical device registration certificates (in vitro diagnostic reagents) for the neutrophil gelatinase associated lipocalin (NGAL) detection kit (colloidal gold method) (E equipment injection standard 20242405154) and β 2-microglobulin (β 2-MG) detection kit (colloidal gold method) (E equipment injection standard 20242405155).
    2025Year
    the company obtained three product medical device registration certificates (in vitro diagnostic reagents) for β 2-microglobulin (β 2-MG) detection kit (fluorescence immunoassay) (E-Xie Zhuzhun 20252405361)