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ONEJECT Smart Syringe 0.5 ml Early Activation 23Gx1"

by PT Oneject Indonesia EUDAMED

Withdrawn Not intended for the EU market

Ref 02437Model Sterile Auto Disable Syringe with Safety Needle

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8990067ADSSIP5T Basic UDI-DIDate21 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  • Withdrawn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European Union — CE/MDR Withdrawn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 Smart Syringe
Model / Reference
Sterile Auto Disable Syringe with Safety Needle, 02437
Primary DI / UDI-DI
08990067024373
Basic UDI-DI
8990067ADSSIP5T
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

Show 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