Atlas Medical GmbH
Active in EUDAMEDGermanyfrom SRN EUDAMED FDA SRN DE-MF-000029961
- Devices
- 179
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
What Atlas Medical GmbH makes
Atlas Medical GmbH produces in vitro diagnostic (IVD) reagents and test kits, including blood grouping reagents such as Anti-A, Anti-B, and Anti-D, as well as monoclonal reagents for serological testing. Their portfolio also encompasses latex agglutination reagents for detecting pathogens like *Salmonella*, *Streptococcus*, and *Proteus*, alongside specialized tests for urinary tract infections and D-dimer assays. Additionally, they manufacture rapid lateral flow tests and multi-parameter urine analysis strips for point-of-care use.
The company’s devices fall under IVD Annex II List A, IVD General, and self-testing categories, with all products listed in the EU’s eudamed registry. Based in Germany, the portfolio adheres to EU IVD regulations and is distributed within the European market framework.
Catalogue
Search and filter all 179 devicesShowing 51-100 of 179
Company details
- EUDAMED SRN
- DE-MF-000029961
- EU VAT number
- DE323236770
- EUDAMED status
- Active
- EUDAMED registered name
- Atlas Medical GmbH
- Registered address
- 3, Ludwig-Erhard-Ring, 15827, Blankenfelde-Mahlow OT Dahlewitz, Germany
- Website
- www.atlas-medical.com/
- facebook.com/Atlas.Medical.GmbH
- [email protected]
- Phone
- +4933708355030
- PRRC contact
- Saba’a Shtaiwi
FDA establishments
- Atlas Medical Amman Al 'Asimah · JO FEI 3007126977
From the company website
Atlas Medical GmbH is a leading German manufacturer and supplier of high-quality In Vitro Diagnostic (IVD) reagents and kits, serving 95 countries worldwide. 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. 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. Driven by an experienced Research and Development team, we continuously develop innovative diagnostic solutions that contribute to the advancement of the IVD industry. We offer flexible OEM and private-label manufacturing services, bulk reagents, and technology transfer solutions. High-quality Blood Grouping reagents, Latex ASO, CRP, RF, Waaler Rose Latex, HCG, SLE, Staphylococcus, D-Dimer, manufacturer of Toxo Latex and Rubella. Our best product is H. Pylori Antigen Elisa, and we do technology transfer on it and all Elisa products as well. IVD Manufacturer, Diagnostic Reagents Manufacturer, Diagnostic Kits Manufacturer, German IVD Manufacturer, CE Marked Diagnostic Kits, ISO 13485 Diagnostic Manufacturer, OEM Diagnostic Manufacturer, Private Label Diagnostic Kits, Bulk Diagnostic Reagents, Rapid Test Manufacturer, Blood Grouping Reagents, Clinical Chemistry Reagents, Latex Agglutination Kits, ELISA Kits, Drug of Abuse Tests, Chemiluminescence Immunoassay CLIA Reagents, Laboratory Diagnostic Solutions, Medical Laboratory Reagents, In Vitro Diagnostics (IVD), OEM Rapid Test Manufacturer, Blood Typing Reagents Diagnostic, Analyzer Manufacturer, Point-of-Care Testing (POCT).