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ChainPro™ Real-Time Fluorescence Quantitative PCR Instrument

by Vitrosens Biotechnology Inc. EUDAMED

Active European Union

Ref NGX8-4F

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number868459503NGX84FTJ Basic UDI-DIDate17 Sep 2025RegisteredStatusActive

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  • Withdrawn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
Real-Time Fluorescence Quantitative PCR Instrument
Model / Reference
NGX8-4F
Primary DI / UDI-DI
08684595032374
Basic UDI-DI
868459503NGX84FTJ
EMDN Code
W02050199 Nucleic acid testing instruments except micro-arrays - other
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
TR-MF-000026452

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See all devices from Vitrosens Biotechnology Inc. →

Properties

  • Near-Patient Testing
  • Professional Testing
  • Companion Diagnostics
  • Surgical Instrument

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • New Device: No