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Atlas Medical GmbH

Active in EUDAMED

Germanyfrom SRN EUDAMED FDA SRN DE-MF-000029961

Devices
179
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA establishment

Catalogue179

Newest first, page 1 of 4

Showing 1-50 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
Phone
+4933708355030
PRRC contact
Saba’a Shtaiwi(public in EUDAMED)

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Atlas Medical Amman Al 'Asimah · JO FEI 3007126977

From the company website

Read 18 Sep 2026

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).

From the manufacturer's own website. Source

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.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Frequently asked questions

How many devices does Atlas Medical GmbH have in the registry?

The registry currently lists 179 devices for Atlas Medical GmbH. Devices recorded under merged duplicate company entries are counted once.

Which registries list Atlas Medical GmbH's devices?

Among its 50 most recently registered devices, Atlas Medical GmbH has devices listed in EUDAMED (50 devices).

What risk classes do Atlas Medical GmbH's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Atlas Medical GmbH's devices are IVD general, IVD Annex II List A and IVD devices for self-testing. Each device page shows its own class and authorisation.

What are the newest devices from Atlas Medical GmbH in the registry?

The most recently registered devices listed for Atlas Medical GmbH include Atlas, Atlas URS 11 Parameters: Leucocytes, Nitrite, Urobilinogen, Protein, pH, Blood, Specific Gravity, Ketone, Bilirubin, Glucose, Ascorbic Acid, 100 Strips/Bottle., Atlas Medical and Atlas Pregnancy HCG Test Device (Urine/Serum), Individually Pouched, 20 Tests/Box.

Which FDA establishments are linked to Atlas Medical GmbH?

1 FDA establishment is linked to Atlas Medical GmbH in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.