Founded in 1996, Atlas Medical GmbH is a leading German manufacturer and supplier of high-quality In Vitro Diagnostic (IVD) reagents and kits, serving customers in more than 95 countries worldwide. We are committed to delivering reliable, innovative, and cost-effective diagnostic solutions that meet the evolving needs of healthcare professionals and laboratories across the globe.
Our core expertise lies in the development and manufacture of Blood Grouping Reagents, Latex Serology Reagents, Clinical Chemistry Reagents, Immunoassays (including ELISA), and Lateral Flow Rapid Tests. Through continuous innovation and technical excellence, we provide a comprehensive portfolio of diagnostic products that support laboratories in delivering accurate and dependable results.
Headquartered in Blankenfelde-Mahlow, Berlin, Germany, Atlas Medical also maintains offices in the United Kingdom, Jordan, and the UAE, providing strong regional support and global customer service. Our manufacturing operations are designed and managed in accordance with internationally recognized quality standards, ensuring consistent product quality and reliable supply.
Quality is at the heart of everything we do. Our quality management system is certified to ISO 13485, and the majority of our products are CE marked. Our manufacturing processes are designed to meet US FDA manufacturing requirements and other applicable international regulatory standards, reflecting our commitment to quality, safety, and compliance.
Driven by an experienced Research and Development team, we continuously develop innovative diagnostic solutions that contribute to the advancement of the IVD industry. In addition to our branded product portfolio, we offer flexible OEM and private-label manufacturing services, bulk reagents, and technology transfer solutions to support partners seeking to localize IVD manufacturing and expand their diagnostic capabilities.
With nearly three decades of experience, Atlas Medical continues to build long-term partnerships by delivering quality, innovation, and exceptional customer support worldwide.
Our mission is to develop, produce and provide our customers with high quality products and excellent customer services through deep understanding of customers’ needs and perception, recruitment of high caliber professionals & technicians, adopting strict quality assurance and control procedures and embracing new scientific advancements in the medical lab diagnostic field.
Our products are manufactured in accordance to the standards as set in the European In-Vitro Diagnostic Directive 98/79/EC. This has led to the successful attainment of Annex IV Full Quality Assurance Certification and the declaration of conformity for CE marking purposes for many of our IVD products, either self-declared or through our Notified Body LNE/G-MED in France. To complete the quality assurance scheme the company has put in place a robust Quality Management and Enhancement System that has concluded in the successful attainment of ISO13485: 2016 certificate.
The company also offers a number of OTC products that have been certified by LNE/G-MED to Annex III.6 of the CE IVD directive for home use. Furthermore, the company also adheres to the US-FDA regulations and had already FDA-cleared few products for the US market. Our products are registered in numerous countries. Our regulatory team is experienced to provide all the supporting documents to register our products in more countries.
We have assigned and adopted high standards of performance for our products to ensure that batch after batch our products are produced at consistently high quality.
We strive to supply our customers with quality products and services that will meet or exceed their expectations.
We are committed to continuously develop and innovate new products and play an active role in the advancement of medical diagnostic reagents and assays.
We take environmental issues very seriously and seek to provide a motivating & comfortable working atmosphere that creates team spirit to ensure increased efficiency, performance and productivity.
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