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Human HER-2 gene amplification detection probe

by Oacp Ie Ltd EUDAMED

Active European Union

Ref FP-001Model fp-001

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5391540380FP-001SL Basic UDI-DIDate20 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Human HER-2 gene amplification detection probe
Model / Reference
fp-001
Primary DI / UDI-DI
53915403800015
Basic UDI-DI
5391540380FP-001SL
Direct Marketing DI
53915403800015
EMDN Code
W01030703 DNA in situ hybridisation reagents
Device Class
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IE-MF-000003506

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Properties

Show properties
  • Reagent
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No