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Almac TP53 Clinical Trial Assay (CTA) v3

by Almac Diagnostic Services Limited EUDAMED

Active European Union

Ref Almac TP53 Clinical Trial Assay (CTA) v3

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-AlmacTP53CTAv384 Basic UDI-DIDate25 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Almac TP53 Clinical Trial Assay (CTA) v3
Model / Reference
Almac TP53 Clinical Trial Assay (CTA) v3
Primary DI / UDI-DI
D-AlmacTP53CTAv384
Basic UDI-DI
B-AlmacTP53CTAv384
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

Show 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