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NeXgen 16HP

by Zinexts Life Science Corp. Taiwan EUDAMED

Ref 131A1 EMDN W02050116

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number471988968AA131F6 Basic UDI-DIDate19 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  • Withdrawn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 · synced 22 Oct 2026

Model / Reference
131A1
Primary DI / UDI-DI
04719889680154
Basic UDI-DI
471988968AA131F6
EMDN Code
W02050116 Nucleic acid testing integrated extraction /amplification /detection systems
Device Class
Class A
Market of Registration
Italy

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 59de692f-0bd8-48da-9e61-03a9679ae7d6 61 fields · synced 22 Oct 2026