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PNPLA3 Genotyping Clinical Trial Assay (CTA)

by Almac Diagnostic Services Limited EUDAMED

Active European Union

Ref PNPLA3 Genotyping CTA

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-PNPLA3GenotypingCTAE7 Basic UDI-DIDate25 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
PNPLA3 Genotyping Clinical Trial Assay (CTA)
Model / Reference
PNPLA3 Genotyping CTA
Primary DI / UDI-DI
D-PNPLA3GenotypingCTAE7
Basic UDI-DI
B-PNPLA3GenotypingCTAE7
EMDN Code
W010699 Genetic tests - other
Device Class
Class IVD General
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
XI-MF-000024200

Other devices from Almac Diagnostic Services Limited

Properties

  • Human Tissues
  • Reagent
  • Professional Testing
  • Surgical Instrument

Other properties (6)

  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No