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ZiXpress Viral RNA Extraction Kit (960) HT

by Zinexts Life Science Corp. EUDAMED

Active European Union

Ref 312B042C

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number471988968312B044Z Basic UDI-DIDate29 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
ZiXpress Viral RNA Extraction Kit
Model / Reference
312B042C
Primary DI / UDI-DI
04719889680659
Basic UDI-DI
471988968312B044Z
EMDN Code
W02069085 Various sample processing instruments - consumables
Device Class
Class A
Market of Registration
Portugal

Manufacturer details

EUDAMED SRN
TW-MF-000026758
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

  • Reagent

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No