About Kangdaan

Shenzhen KangDaAn Biological Technology Co, Ltd.

COMPANY PROFILE

Shenzhen KangDaAn Biological Technology Co, Ltd. is located in Nanshan District, Shenzhen, focusing on the research and development, production and sales of laboratory consumables, in vitro diagnostic reagents and equipment, and is committed to providing global customers with high-quality overall solutions for laboratory consumables.

With more than 300 employees and a plant area of nearly 15,000 square meters, KangDaAn has four production bases and two research and development centers, and its products cover nucleic acid detection, molecular diagnosis, medical testing, virus detection, cell culture, immunotherapy and other aspects.The company has its own precision injection molding factory, flocking factory, sponge factory, finished product packaging factory, 5000㎡+ storage space, has a complete supply chain and strict standard production process, and at the same time has in line with GMP and ISO13485 requirements of 100,000 purification workshop.

The main products include aseptic sampling swab, antigen and antibody sampling consumables, cervical brush, virus sampling tube, cell preservation solution, IVD equipment, testing reagents, etc. Listed products have obtained Class II aseptic registration certificate, ISO13485, EU CE0197(MDR), US FDA, UK MHRA, Australia TGA, France FSC, Vietnam FSC, Singapore HSA, Thailand TFDA, Indonesia IZIN EDAR, Japan PMDA, Malaysia MDA.

Focusing on IVD sampling consumables and relying on customer needs, Kangdaan Biology has built five major technology platforms such as laboratory consumables, in vitro diagnostic reagents, in vitro diagnostic equipment, biological raw materials and molecular diagnostics.The company's products are widely used in life science, pharmaceutical industry, environmental protection, food safety, medical (government institutions, clinical medicine, laboratories) and other fields, products sold in more than 40 countries around the world.

The company has always been 'efficient innovation, the pursuit of excellence' for the corporate purpose, continuous innovation, in order to create more customer value, and to contribute to the development of medical devices and human health.

Billions

使用人次

Partners

服务全球多个国家和地区

300

Employees

Company Culture

Mission

committed to providing overall solutions for laboratory consumables.

Vision

To become the leading brand in the field of overall solutions for laboratory consumables.

Values

Customer: Creating Customer Value
Principle: System first, leadership second
Team: Sharing joys and sorrows, challenging the limits
Responsibility: Responsible for oneself, for the enterprise, and for society

Social responsibility

Kangda'an has always regarded product quality as the fundamental survival principle, strictly controlling quality requirements and preventing the outflow of unqualified products. Therefore, a strict product management system has been established to meet the requirements of medical device production quality management standards; Strictly following relevant laws and regulations to operate the system, actively maintaining continuous improvement and improvement of quality management, continuously communicating and communicating with relevant personnel at home and abroad, and in the future, Kangda'an will continue to expand its sales capacity and contribute to society.

Certificates

Business License

the License for Medical Device Manufacturing Enterprises

Certifications by Domestic & Foreign Authorities

Cervical Brushes Class II Medical Device Registration Certificate

Development Path

2022

2021

2020

2019

2018

2017

2022年

• In September, it obtained Malaysia MDA certification
• In August, it obtained Japan PMDA certification
• in July, it obtained IZIN EDAR certification in Indonesia
• In April, it obtained CE0197 certification under the new EU medical device regulation MDR system
• In April, it obtained Thailand TFDA certification
• In April, it was certified by Singapore HSA
• In March, it obtained the free sales certificate from FSC of France and FSC of Vietnam
• In February, it obtained the TGA system certification in Australia

2021年

• KangDaAn passed Britain MHRA Registration.
• KangDaAn obtained America FDA Certification.

2020年

• KangDaAn obtained EU CE0197 Certification.
• KangDaAn passed the certification of ISO13485:2016 medical device production quality management system.
• KangDaAn obtained the Class II medical device registration certificate.

2019年

• KangDaAn successfully developed a variety of products, such as sampling swab, cell preservation solution, cervical brush, IVD equipment and so on.

2018年

• KangDaAn has passed various inspection indicators and won the license for medical device manufacturing enterprises.

2017年

• Shenzhen KangDaAn Biological Technology Co, Ltd.was established.

Production Environment