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FLEX Polyclonal Rabbit Anti-Helicobacter Pylori, Ready-to-Use (Dako Omnis)

by Agilent Technologies Singapore (International) Pte Ltd

Ref GA52361-2Model GA523/IR523

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number570057R0301P3007C014901NC Basic UDI-DI 05700572033400UDI-DIDate16 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
FLEX Polyclonal Rabbit Anti-Helicobacter Pylori, Ready-to-Use
Model / Reference
GA523/IR523, GA52361-2
Primary DI / UDI-DI
05700572033400
Basic UDI-DI
570057R0301P3007C014901NC
EMDN Code
W0102030199 Cancer antigens - other
Device Class
Class C
EU 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

See all devices from Agilent Technologies Singapore (International) Pte Ltd →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No