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PsorX-LabDisk

EUDAMED

Class IVD General (EU MDR)

Ref DXA0000082

by Dermagnostix GmbH

Identity

Device Name: PsorX-LabDisk EUDAMED
Model / Reference: DXA0000082 EUDAMED

Identifiers

Primary DI / UDI-DI: 04262367270014 EUDAMED
Basic UDI-DI: B-04262367270014 EUDAMED
EMDN Code: W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

Category: Nucleic acid sample preparation instrument IVD

PsorX-LabDisk by Dermagnostix GmbH — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

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Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer: Dermagnostix GmbH
EUDAMED SRN: DE-MF-000025137

Sources (1)

EUDAMED 3afaf226-8bb7-4872-9e12-dd177707fd42 61 fields · synced Jul 14, 2026