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MagNXT FFPE DNA Extraction Kit

EUDAMED

Class A (EU MDR)

Ref G2M810007-192TModel G2M810007

by Genes 2Me Private Limited

Identity

Trade Name
MagNXT FFPE DNA Extraction Kit EUDAMED
Device Name
MagNXT FFPE DNA Extraction Kit EUDAMED
Model / Reference
G2M810007 EUDAMED
G2M810007-192T EUDAMED

Identifiers

Primary DI / UDI-DI
08906178200506 EUDAMED
Basic UDI-DI
890617820G2M810007GG EUDAMED
Direct Marketing DI
08906178200506 EUDAMED
EMDN Code
W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Belgium EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

MagNXT FFPE DNA Extraction Kit by Genes 2Me Private Limited — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

EUDAMED SRN
IN-MF-000035953
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (1)

  • EUDAMED 53dea081-2b78-4817-b64e-af3cff7fca04 61 fields · synced Jun 18, 2026