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Onclarity

by Becton, Dickinson and Company United States EUDAMED

Ref 441993

EMDN W0105041005

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number038290JKQSRVNRK3 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 24 Oct 2026

Device Name
BD Control Set for the BD Onclarity™ HPV Assay
Model / Reference
441993
Primary DI / UDI-DI
00382904419936
Basic UDI-DI
038290JKQSRVNRK3
EMDN Code
W0105041005 Other hpv - na reagents
Device Class
Class C
Market of Registration
Belgium

Manufacturer details

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

Other devices from Becton, Dickinson and Company

See all devices from Becton, Dickinson and Company →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 00382904419936|038290JKQSRVNRK3 61 fields · synced 24 Oct 2026