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MagNXT Tissue & body fluids Nucleic acid extraction kit

EUDAMED

Class A (EU MDR)

Ref G2M212121MG-480TModel G2M212121Ref G2M212121-250TRef G2M212121TK-480TRef G2M212121-50T

by Genes 2Me Private Limited

Identity

Trade Name
MagNXT Tissue & body fluids Nucleic acid extraction kit EUDAMED
Device Name
MagNXT Tissue & body fluids Nucleic acid extraction kit EUDAMED
Model / Reference
G2M212121 EUDAMED
G2M212121MG-480T EUDAMED
G2M212121-250T EUDAMED
G2M212121TK-480T EUDAMED
G2M212121-50T EUDAMED

Identifiers

Primary DI / UDI-DI
08906178200681 EUDAMED
08906178200414 EUDAMED
08906178200629 EUDAMED
08906178200407 EUDAMED
Basic UDI-DI
890617820G2M212121EF EUDAMED
Direct Marketing DI
08906178200681 EUDAMED
08906178200414 EUDAMED
08906178200629 EUDAMED
08906178200407 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 Tissue & body fluids Nucleic acid 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 (4)

  • EUDAMED f2d9c5f1-ad8e-438e-af7f-246e63c30da0 61 fields · synced Jul 29, 2026
  • EUDAMED 5f0bd0f9-1817-487c-a0a3-d72620120c27 61 fields · synced May 18, 2026
  • EUDAMED 27d83bd3-cb5c-4df3-83f0-65d3a128b299 61 fields · synced May 19, 2026
  • EUDAMED 35b1864e-ca7d-48e1-b56d-5cb0c8e7db3a 61 fields · synced May 19, 2026