Company Profile

Focus on the research, development, production, sales and service of medical devices

Anji Huayong Biotechnology Co., Ltd.

Restructuring the boundaries of medical devices with innovation, every product is a safety commitment


2021 Year

Company establishment time

21000

Land area

30 +

Team Members

5 +

Product series

300 +

Partners

Anji Huayong Biotechnology Co., Ltd. was established in May 2021 with a registered capital of 80 million yuan. As a company focusing on the medical device industry, it integrates research, development, production, sales and service. It mainly engages in the production and sales of Class I and Class II medical devices. The company strives to improve the core competitiveness and industry recognition of its products, build technological barriers, and build a team that is committed to learning and progress. It pursues excellence in product quality, technical skills, and service quality, pursuing perfection with a sincere heart and rigorous attitude to serve the society.

Located at No. 1765, Kangyi Road, Xiaoyuan Street, Anji County, the company mainly engages in the production and sales of Class I and Class II medical devices, and has professional production equipment, workshops and factories built according to national medical device GMP standards.

The company currently has 25 employees, including 5 with bachelor's degrees or above, and 10 with junior college degrees or above. The proportion of technical personnel is 42.3%. Currently, there are 3 people in the quality control department, 2 in the production technology department, 2 in the engineering equipment department, 2 in the warehouse, 2 in the general office, 1 in finance, and 11 workshop workers.

Anji Huayong Bio-Technology Co., Ltd. has completed the acquisition of the factory and will have a factory building of 21,000 square meters. The entire construction cycle is 2 years and will be completed in 2024. The main products are medical consumables. Currently, the construction of 4 workshops has been completed, with an investment of approximately 40 million yuan. It has 8 fully automatic disposable sampler production lines, 20 fully automatic packaging lines, and 2 sets of sterilization and exhaust gas treatment devices, with an annual production capacity of 500 million disposable samplers.

Various departments of the company have done a lot of work in the operation of the quality management system. A preliminary system of raw material and finished product release, documentation, non-conforming product management, customer complaint handling, corrective and preventive actions, training, and personnel hygiene has been established. The quality policy and objectives are consistent with the system operation and business operations of the company; through continuous establishment, construction and implementation of the quality management system, the quality awareness of the company's organization and individuals has been improved, promoting the continuous improvement of the effectiveness of the quality system; the effectiveness, completeness and suitability of the quality system meet the current development needs of the company.

The company has complete production equipment; inspection equipment has covered all projects: such as microbiological inspection equipment, EO inspection equipment, and stability test equipment.

The company has undergone registration and certification at various stages. The following is the status of the obtained registration certificates:

On July 12, 2022, the disposable sterile sampling swab completed registration, registration certificate number: Zexie Zhuzhun 20222221029;

On July 15, 2022, the disposable sterile sampling swab obtained a production license, license number: Zheyao Jianxie Shengchan Xu 20220077;

On August 16, 2022, the CE registration certificate was obtained;

On August 16, 2022, the ISO13485 certificate was obtained.

On June 23, 2024, the medical gauze pad obtained the registration certificate.

Qualification Certificate


Medical Device Production License

Medical Device Production License

Medical gauze registration certificate

Medical gauze registration certificate

ISO 13485 certificate

ISO 13485 certificate

CE certificate

CE certificate

Company Environment


Factory equipment

Factory equipment

Factory equipment

Factory equipment

Corporate environment

Corporate environment

Corporate environment

Corporate environment