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HER2 IQFISH pharmDx

by Agilent Technologies Singapore (International) Pte Ltd Singapore EUDAMED

Ref K573111-2Model K5731

EMDN W01060213

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-SGMF000014448K573111Y5 Basic UDI-DIDate20 Aug 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 24 Oct 2026

Model / Reference
K5731, K573111-2
Primary DI / UDI-DI
D-SGMF000014448K573111Y5
Basic UDI-DI
B-SGMF000014448K573111Y5
EMDN Code
W01060213 Her-2/neu (breast cancer)
Device Class
Class IVD General
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
SG-MF-000014448
Authorised representative
Agilent Technologies Denmark ApS DK-AR-000001443

Other devices from Agilent Technologies Singapore (International) Pte Ltd

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Properties & raw data

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

Sources (1)

  • EUDAMED D-SGMF000014448K573111Y5|B-SGMF000014448K573111Y5 61 fields · synced 24 Oct 2026