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MDM2/CEP12 FISH Clinical Trial Assay (CTA)

by Almac Diagnostic Services Limited

Ref MDM2/CEP12 FISH CTA

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-MDM2CEP12FISHCTA3B Basic UDI-DI D-MDM2CEP12FISHCTA3BUDI-DIDate25 May 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
MDM2/CEP12 FISH Clinical Trial Assay (CTA)
Model / Reference
MDM2/CEP12 FISH CTA
Primary DI / UDI-DI
D-MDM2CEP12FISHCTA3B
Basic UDI-DI
B-MDM2CEP12FISHCTA3B
EMDN Code
W010699 Genetic tests - other
Device Class
Class IVD General
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
XI-MF-000024200

Other devices from Almac Diagnostic Services Limited

Properties

  • Human Tissues
  • Reagent
  • Surgical Instrument

Other properties (7)

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