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Bactec

by Becton, Dickinson and Company United States EUDAMED

Ref 442017

EMDN W0104030303

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number038290KHGPBZJB8Q Basic UDI-DIDate24 Jul 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 BACTEC™ Mycosis IC/F Culture Vials
Model / Reference
442017
Primary DI / UDI-DI
30382904420179
Basic UDI-DI
038290KHGPBZJB8Q
Unit of Use DI
00382904420178
EMDN Code
W0104030303 Bottled media for yeasts and fungi
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
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 30382904420179|038290KHGPBZJB8Q 61 fields · synced 24 Oct 2026