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ONEJECT Auto Disable Syringe 0.5 ml Early Activation 23Gx1"

by PT Oneject Indonesia EUDAMED

Withdrawn Not intended for the EU market

Ref 02448Model Strerile Auto Disable Syringe

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8990067ADSOJI4U Basic UDI-DIDate7 May 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
ONEJECT Auto Disable Syringe
Model / Reference
Strerile Auto Disable Syringe, 02448
Primary DI / UDI-DI
08990067024472
Basic UDI-DI
8990067ADSOJI4U
EMDN Code
A020102010201 Infusion and irrigation syringes, luer cone, 3-piece with needle, single-use
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
ID-MF-000004875
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from PT Oneject Indonesia

Properties

  • Sterile
  • Administering Medicine
  • Measuring Function

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Incorporates Medicinal Product: No