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Miss Sheryl Wang
Manager
Marketing Department
Address:
South Industry Zone, Langfang, Hebei, China
Telephone:
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Account Registered in:
2023
Business Range:
Health & Medicine, Instruments & Meters, Packaging & Printing
Management System Certification:
ISO 13485
Business Type:
Manufacturer/Factory
Main Products:

Company Introduction

Production Capacity

Established in 2004, Atlas Link Biotech (hereinafter referred to as the "Company") specializes in the design, research and development, manufacture, production and sales of in vitro diagnostic reagents and instruments. With headquarter in Beijing, largest production base in Hebei, R&D and sales branches in Hong Kong, Singapore and the United States, since then, Atlas Link Biotech has become a ...
Established in 2004, Atlas Link Biotech (hereinafter referred to as the "Company") specializes in the design, research and development, manufacture, production and sales of in vitro diagnostic reagents and instruments. With headquarter in Beijing, largest production base in Hebei, R&D and sales branches in Hong Kong, Singapore and the United States, since then, Atlas Link Biotech has become a large multinational scientific and technological enterprise with more than 600 employees worldwide. In recent years, the Company has expanded its business scope to the research and development, manufacture and application of high-tech materials, such as product portfolio under NOVAtest eco, and the Beta-Bear Lab, a third-party testing and development center for medical devices, etc...Atlas Link Biotech owns a number of internationally well-known trademarks, including NOVAtest, SENSOtest, Atlas Link, Beta-Bear, as well as dozens of patents and inventions.

Atlas Link Technology Co., Ltd. Was established in 2010 and is located in Langfang City, Hebei Province. It is the largest R&D center and production base for in vitro diagnostic reagents under Atlas Link Biotech. The base occupies a total area of 23, 000 square meters, and has multiple built-in Class 100, 000 clean production workshops and inspection areas, with a total clean area of 1, 200 square meters. The production base is now fully semi-automated and partially automated (for specific products or processes), with a monthly production capacity of 15-40 million tests (depending on the type of products). There are more than 100 permanent employees in the base, more than half of whom are professionals in biomedical engineering and business administration.

Atlas Link Biotech has obtained the Medical Device Production License granted by the National Medical Products Administration (NMPA), to carry out the production activities of in vitro diagnostic medical devices. On this basis, the commitment to quality is the solid foundation for Company's products. As a guarantee of the commitment, the Company has certified according to the ISO 13485: 2016 quality management system requirements.

The Company's products currently involve multiple IVD test platforms, covering more than 200 products in the field of fertility assessment test, infectious disease, vector-borne disease, STD, marker, indicator and addictive substance, which can be intended for diverse uses such as professional use (lab and POCT) and self-testing. Most of the products have obtained CE certifications, FDA approvals, TGA certifications, and domestic Class II and III medical device registration certificates.
Factory Address:
South Industry Zone, Langfang, Hebei, China
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