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Icumedical jelco Hypodermic NEEDLE-PRO Fixed Needle Insulin Syringe

by Sol-Millennium Medical, Inc. EUDAMED

Active European Union

Ref 43125-1Model Insulin Safety Syringe with Fixed Needle (Shield Technology)

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081006243SIG1ZT Basic UDI-DIDate8 Jan 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
SOL-GUARD Insulin Safety Syringe with Fixed Needle
Model / Reference
Insulin Safety Syringe with Fixed Needle (Shield Technology), 43125-1
Primary DI / UDI-DI
00810062430192
Basic UDI-DI
081006243SIG1ZT
Direct Marketing DI
00810062430192
EMDN Code
A0201060301 Insulin syringes with safety systems and fixed needles, single-use
Device Class
Class IIa
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
US-MF-000010890
Authorised representative
Sol-Millennium Europe Sp. z o.o. PL-AR-000010397

Other devices from Sol-Millennium Medical, Inc.

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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