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ONEJECT Hypodermic Syringe with Reuse Prevention Feature 1ml 27G x 3/8"

by PT Oneject Indonesia Indonesia EUDAMED

Ref 04328Model Sterile Hypodermic Syringe with Reuse Prevention Feature EMDN A020102010201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8990067RUPOJIGX Basic UDI-DIDate13 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  • Withdrawn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European Union — CE/MDR Withdrawn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 · synced 24 Oct 2026

Device Name
ONEJECT Hypodermic Syringe with Reuse Prevention Feature
Model / Reference
Sterile Hypodermic Syringe with Reuse Prevention Feature, 04328
Primary DI / UDI-DI
08990067043282
Basic UDI-DI
8990067RUPOJIGX
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED f01e0648-7fee-4333-8f77-c30f64ce6386 61 fields · synced 24 Oct 2026