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FLEX Monoclonal Mouse Anti-Human Epithelial Membrane Antigen, Clone E29, Ready-to-Use (Dako Omnis)

by Agilent Technologies Singapore (International) Pte Ltd Singapore EUDAMED

Ref GA62961-2Model GA629

EMDN W0102030199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-SGMF000014448GA629613Q Basic UDI-DIDate24 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
GA629, GA62961-2
Primary DI / UDI-DI
D-SGMF000014448GA629613Q
Basic UDI-DI
B-SGMF000014448GA629613Q
EMDN Code
W0102030199 Cancer antigens - other
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
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED a7e4c92f-8a09-4069-9681-3a654c430e1a 61 fields · synced 24 Oct 2026