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Gen-C 3.0

by Nuclear Laser Medicine srl Italy EUDAMED

Ref AC004/24

EMDN W0105020309

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number803362992GENHCVD6 Basic UDI-DIDate10 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Gen-C 3.0
Model / Reference
AC004/24
Primary DI / UDI-DI
08033629924589
Basic UDI-DI
803362992GENHCVD6
Direct Marketing DI
08033629924589
EMDN Code
W0105020309 Hepatitis c virus (hcv) genotyping - na reagents
Device Class
Class C
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000025709

Other devices from Nuclear Laser Medicine srl

See all devices from Nuclear Laser Medicine srl →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 08033629924589|803362992GENHCVD6 61 fields · synced 24 Oct 2026