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ISH Pre-Treatment Solution (20x) (Dako Omnis)

by Agilent Technologies Singapore (International) Pte Ltd Singapore EUDAMED

Ref GM301Model GM30111-2 EMDN W01030703

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number570057P3007P3010A022201M8 Basic UDI-DIDate26 May 2026RegisteredStatusActive

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  • Withdrawn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 · synced 25 Oct 2026

Model / Reference
GM30111-2, GM301
Primary DI / UDI-DI
05700572033561
Basic UDI-DI
570057P3007P3010A022201M8
EMDN Code
W01030703 DNA in situ hybridisation reagents
Device Class
Class A
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 05700572033561|570057P3007P3010A022201M8 61 fields · synced 25 Oct 2026