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DNA Prevention Test (v1)

EUDAMED

Class I (EU MDR)

Ref DNA-PR-01Model SW-BUCRef DNA-PR-02

by LykonDX GmbH

Identity

Trade Name: DNA Prevention Test (v1) EUDAMED
Model / Reference: SW-BUC EUDAMED
DNA-PR-01 EUDAMED
DNA-PR-02 EUDAMED

Identifiers

Primary DI / UDI-DI: 04260640119593 EUDAMED
04260640119586 EUDAMED
Basic UDI-DI: 4260640110000112Q EUDAMED
EMDN Code: A1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMED

Classification

Device Class: Class I EUDAMED
Medical Purpose: Entnahme und primäre Aufbewahrung einer Zellprobe aus der Wangenschleimhaut durch Laienanwender in der häuslichen Umgebung. EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Category: General-purpose absorbent tip applicator/swab, single-use

DNA Prevention Test (v1) by LykonDX GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

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Also classified as General-purpose absorbent tip applicator/swab, single-use.

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Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer: LykonDX GmbH
EUDAMED SRN: DE-PR-000005929

Sources (2)

EUDAMED d3c2b288-0628-40eb-96bd-75d324e44356 61 fields · synced Jul 9, 2026
EUDAMED d0d86dc9-86e1-4210-ac33-1f1c86c2069f 61 fields · synced May 18, 2026