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MacroArray Diagnostics

Austria·AT-MF-000030541

Last updated September 18, 2026

About

In the beginning there was a vision to improve and modernize immunodiagnostics. Scientists - like our founder Christian Harwanegg - always strive for disruptive innovation, so after more than a decade with leading companies in the field he decided to start his own enterprise in 2016. Our goal was clear: The newly founded company MADx (MacroArray Diagnostics) offers an allergy test that is supposed to be better, more efficient and easier to use than the ones of the competition. In addition, we wanted to offer the entire value chain from test material to evaluation, the necessary hardware and software to the cloud-based interpretation software RAVEN that always runs in real time.

From the manufacturer's own website. Source

What MacroArray Diagnostics makes

MacroArray Diagnostics produces in vitro diagnostic (IVD) devices for allergy testing, including multiplex arrays like the MAX 9k and MAX 45k for simultaneous analysis of multiple allergens. The company also supplies consumables such as the FOX Food Explorer for food allergen detection, washing solutions, and stop solutions for assay processing. Its portfolio includes hardware platforms like the ALEX² and ALEX³ Allergy Xplorers, alongside software tools such as the RAPTOR Server for data analysis and ConfigXplorer for system configuration, as well as the ALEX Air for environmental allergen monitoring.

The company’s devices are classified under EU regulations as Class A (low-risk) and Class C (moderate-risk) IVDs, with some falling under the broader IVD General category. These products are registered in the EU’s eudamed database, a mandatory repository for in vitro diagnostic medical devices under EU MDR compliance. The manufacturer is based in Austria.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
Austria
Address
59, Top 4, Lemböckgasse, Wien, Austria
Website
www.madx.com
LinkedIn
—
Facebook
—
Phone
+43 1 8652573
PRRC Contact
Robert Maczejka
EUDAMED SRN
AT-MF-000030541
FDA FEI Number
—
DUNS Number
—

Catalogue (14)

DeviceModel / ReferenceRegistriesClassStatus
FOX Food Explorer 80-5001-01
EUDAMED
IVD GeneralActive
Washing Solution 4x conc. 00-5003-01
EUDAMED
Class AActive
MAX 9k 17-0000-01
EUDAMED
Class AActive
ALEX² Allergy Xplorer 02-2001-01
EUDAMED
Class CActive
ALEX³ Allergy Xplorer 03-2001-01
EUDAMED
Class CActive
ALEX Air 06-5001-01
EUDAMED
Class CActive
RAPTOR SERVER Analysis Software 22-0000-01
EUDAMED
Class CActive
ALEX³ Allergy Xplorer 03-5001-01
EUDAMED
Class CActive
Stop Solution 00-5007-01
EUDAMED
Class AActive
MAX 45k 16-0000-01
EUDAMED
Class AActive
ConfigXplorer 30-0100-01
EUDAMED
Class AActive
ALEX² Allergy Xplorer 02-5001-01
EUDAMED
Class CActive
ALEX Food 07-5001-01
EUDAMED
Class CActive
ImageXplorer 11-0000-01
EUDAMED
Class AActive

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