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Gencyst Nucleic Acid Extraction Kit

by Gencyst Oy EUDAMED

Active European Union EUDAMED: not on the EU market

Ref GN-250

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number642983032322GNAE250D6 Basic UDI-DIDate1 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Nucleic Acid Extraction Kit
Model / Reference
GN-250
Primary DI / UDI-DI
06429830323228
Basic UDI-DI
642983032322GNAE250D6
Unit of Use DI
06429830323297
EMDN Code
W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
Device Class
Class A

Manufacturer details

EUDAMED SRN
FI-MF-000057478

Other devices from Gencyst Oy

Properties

  • Microbial Substances
  • Reagent
  • Professional Testing
  • New Device

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No