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COL1A1/PDGFB gene fusion t(17;22) probe reagent

by Oacp Ie Ltd Ireland EUDAMED

Ref FP-137

EMDN W01030703

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-5391540380FP-137TE67 Basic UDI-DIDate21 Dec 2025RegisteredStatusActive

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
COL1A1/PDGFB gene fusion t(17;22) probe reagent
Model / Reference
FP-137
Primary DI / UDI-DI
D-5391540380FP-137TE67
Basic UDI-DI
B-5391540380FP-137TE67
EMDN Code
W01030703 DNA in situ hybridisation reagents
Models / Variants
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IE-MF-000003506

Other devices from Oacp Ie Ltd

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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 30edc1da-27c3-4f9a-95ea-1349ae5d0d49 61 fields · synced 22 Oct 2026