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Preset

by Becton, Dickinson and Company United States EUDAMED

Ref 364415

EMDN A02010501

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number038290YPFLKUBXMB Basic UDI-DIDate8 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
BD Preset™ Eclipse™ Arterial Blood Collection Syringe BD Preset™ Arterial Blood Collection Syringe
Model / Reference
364415
Primary DI / UDI-DI
50382903644150
Basic UDI-DI
038290YPFLKUBXMB
Unit of Use DI
00382903644155
EMDN Code
A02010501 Blood gas analysis, syringes with needle w/o safety system and kits
Device Class
Class IIa
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000019182
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
  • Sterile
  • CMR Substance
  • Animal Tissues
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 50382903644150|038290YPFLKUBXMB 61 fields · synced 24 Oct 2026