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Sign in to claim this brandMacroArray 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
- —
- —
- [email protected]
- Phone
- +43 1 8652573
- PRRC Contact
- Robert Maczejka
- EUDAMED SRN
- AT-MF-000030541
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| FOX Food Explorer | 80-5001-01 | EUDAMED | IVD General | Active |
| Washing Solution 4x conc. | 00-5003-01 | EUDAMED | Class A | Active |
| MAX 9k | 17-0000-01 | EUDAMED | Class A | Active |
| ALEX² Allergy Xplorer | 02-2001-01 | EUDAMED | Class C | Active |
| ALEX³ Allergy Xplorer | 03-2001-01 | EUDAMED | Class C | Active |
| ALEX Air | 06-5001-01 | EUDAMED | Class C | Active |
| RAPTOR SERVER Analysis Software | 22-0000-01 | EUDAMED | Class C | Active |
| ALEX³ Allergy Xplorer | 03-5001-01 | EUDAMED | Class C | Active |
| Stop Solution | 00-5007-01 | EUDAMED | Class A | Active |
| MAX 45k | 16-0000-01 | EUDAMED | Class A | Active |
| ConfigXplorer | 30-0100-01 | EUDAMED | Class A | Active |
| ALEX² Allergy Xplorer | 02-5001-01 | EUDAMED | Class C | Active |
| ALEX Food | 07-5001-01 | EUDAMED | Class C | Active |
| ImageXplorer | 11-0000-01 | EUDAMED | Class A | Active |
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