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Micro-Fine Insulin Syringes

by embecta Medical II LLC EUDAMED

Active European Union

Ref 324883Model Insulin Syringe - Polybagged

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0383017INSLSYRNPBJR6K Basic UDI-DIDate19 Aug 2025RegisteredStatusActive

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  • Withdrawn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
Micro-Fine; Ultra-Fine
Model / Reference
Insulin Syringe - Polybagged, 324883
Primary DI / UDI-DI
10383017488311, 00383017488314
Basic UDI-DI
0383017INSLSYRNPBJR6K
Unit of Use DI
80383017488389
EMDN Code
A02010601 Insulin syringes with fixed needle, single-use
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
US-MF-000044225
Authorised representative
embecta Penel Limited IE-AR-000040945

Other devices from embecta Medical II LLC

See all devices from embecta Medical II LLC →

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