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Dermagnostix GmbH

Germany·DE-MF-000025137

Last updated September 18, 2026

About

Dermagnostix offers innovative, automated molecular diagnostic solutions for dermatopathologists and dermatologists. Psoriasis v. Eczema Diagnostics Test🧬

From the manufacturer's own website. Source

What Dermagnostix GmbH makes

Dermagnostix GmbH produces diagnostic test systems for distinguishing psoriasis from eczema, including a disposable test disk (PsorX-LabDisk) and an automated analyzer (LabDisk-Analyzer) for molecular analysis. The company also supplies connectivity solutions to integrate these systems with laboratory workflows.

The company’s products fall under Class A and In Vitro Diagnostic (IVD) General device classifications, and they are registered in the EU’s eudamed database. The manufacturer is based in Germany.

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

Frequently asked questions

What types of medical devices does Dermagnostix GmbH manufacture?

Dermagnostix GmbH develops diagnostic test systems specifically designed to differentiate between psoriasis and eczema. Their portfolio includes a disposable test disk called the PsorX-LabDisk, an automated analyzer called the LabDisk-Analyzer for molecular analysis, and connectivity solutions to streamline integration with laboratory workflows. These devices are tailored for dermatopathologists and dermatologists.

Where is Dermagnostix GmbH based, and what regulatory database lists its devices?

Dermagnostix GmbH is headquartered in Germany. Their devices are registered in the eudamed database, which is the EU’s official registry for medical devices. This listing ensures transparency regarding their authorized products within the European market.

How are Dermagnostix’s devices classified under medical device regulations?

Dermagnostix’s products fall under Class A and In Vitro Diagnostic (IVD) General classifications. Class A devices are typically low-risk, while IVD General classification applies to diagnostic tests that do not pose significant health risks but still require regulatory oversight. These classifications help determine the regulatory requirements for their development, manufacturing, and market placement.

What is the primary purpose of Dermagnostix’s automated analyzer and connectivity solutions?

The LabDisk-Analyzer automates molecular analysis for the PsorX-LabDisk, enabling faster and more precise differentiation between psoriasis and eczema. The connectivity solutions bridge these systems with laboratory information management software, improving workflow efficiency and data integration. Together, they enhance diagnostic accuracy and operational streamlining for healthcare providers.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Germany
Address
4a, Engesserstraße, Freiburg, Germany
Facebook
—
Phone
+49 761 60046010 (from company website)
PRRC Contact
Martin Meyer
EUDAMED SRN
DE-MF-000025137
FDA FEI Number
—
DUNS Number
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Catalogue (3)

DeviceModel / ReferenceRegistriesClassStatus
PsorX-LabDisk DXA0000082
EUDAMED
IVD GeneralActive
LabDisk-Analyzer ESDR12-MB-1000
EUDAMED
Class AActive
Connectivity Solution DXA0000100
EUDAMED
Class AActive

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