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Del(11)(p15.5) (11p15.5) deletion probe reagent

by Oacp Ie Ltd Ireland EUDAMED

Ref FP-142

EMDN W01030703

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-539154038FP-142ZH8B Basic UDI-DIDate11 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Del(11)(p15.5) (11p15.5) deletion probe reagent
Model / Reference
FP-142
Primary DI / UDI-DI
D-539154038FP-142ZH8B
Basic UDI-DI
B-539154038FP-142ZH8B
EMDN Code
W01030703 DNA in situ hybridisation reagents
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IE-MF-000003506

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Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 4ae10fe0-4bfb-4c04-96d3-279313061bb5 61 fields · synced 22 Oct 2026