Skip to content

SAFEJECT Disposable Syringe Without Needle 10 ml

by PT Oneject Indonesia Indonesia EUDAMED

Ref 05458Model Sterile Disposable Syringe without Needle EMDN A020102010201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8990067DSWOOJIHY 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  • Withdrawn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European Union — CE/MDR Withdrawn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 · synced 24 Oct 2026

Device Name
SAFEJECT Disposable Syringe without Needle
Model / Reference
Sterile Disposable Syringe without Needle, 05458
Primary DI / UDI-DI
08990067054585
Basic UDI-DI
8990067DSWOOJIHY
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 223da8fe-65db-47b1-83ab-a79943d68f8e 61 fields · synced 24 Oct 2026