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UGT1A1 Real Time (FRET) Plus

by Nuclear Laser Medicine srl Italy EUDAMED

Ref FA187/10 EMDN W010699

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number803362992PHARMAGENPLUSFB Basic UDI-DIDate10 Jul 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  • Withdrawn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

Device Name
UGT1A1 Real Time (FRET) Plus
Model / Reference
FA187/10
Primary DI / UDI-DI
08033629924602
Basic UDI-DI
803362992PHARMAGENPLUSFB
Direct Marketing DI
08033629924602
EMDN Code
W010699 Genetic tests - other
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 36ce1d73-131e-470f-aec0-5dd3779d10b4 61 fields · synced 22 Oct 2026