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RARA Clinical Trial Assay (CTA)

by Almac Diagnostic Services Limited Liability Company EUDAMED

Active European Union

Ref RARA CTA

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-RARACTA7R Basic UDI-DIDate30 Jun 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  • Withdrawn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
RARA Clinical Trial Assay (CTA)
Model / Reference
RARA CTA
Primary DI / UDI-DI
D-RARACTA7R
Basic UDI-DI
B-RARACTA7R
EMDN Code
W010699 Genetic tests - other
Device Class
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
US-MF-000025491
Authorised representative
Almac Diagnostic Services Ireland Limited IE-AR-000024248

Other devices from Almac Diagnostic Services Limited Liability Company

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