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Onclarity COR

by Becton, Dickinson and Company United States EUDAMED

Ref 443981

EMDN W02050185

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number038290HDXYQEYKGS Basic UDI-DIDate13 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
BD Onclarity™ HPV Extraction Reagent Trough for BD COR™
Model / Reference
443981
Primary DI / UDI-DI
30382904439812
Basic UDI-DI
038290HDXYQEYKGS
Unit of Use DI
00382904439811
EMDN Code
W02050185 Nucleic acid testing instruments except micro-arrays - consumables
Device Class
Class A
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000018910
Authorised representative
Becton Dickinson Ireland Limited IE-AR-000007610

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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 30382904439812|038290HDXYQEYKGS 61 fields · synced 23 Oct 2026