Skip to content

ZiXpress 32 Dx

by Zinexts Life Science Corp. Taiwan EUDAMED

Ref 112C1

EMDN W02069099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number471988968AA112F2 Basic UDI-DIDate20 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
112C1
Primary DI / UDI-DI
04719889680086
Basic UDI-DI
471988968AA112F2
EMDN Code
W02069099 Various sample processing instruments - other
Device Class
Class A
Market of Registration
Portugal

Manufacturer details

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

Other devices from Zinexts Life Science Corp.

See all devices from Zinexts Life Science Corp. →

Properties & raw data

Show properties, registry sources and raw records
  • Surgical Instrument
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 6277520c-a0a6-416b-b794-108496275b3e 61 fields · synced 22 Oct 2026