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SOL-M Insulin Syringe

by Sol-Millennium Medical, Inc. United States EUDAMED

Ref 161311564BModel Insulin Standard Syringe with fixed needle EMDN A02010601

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081006243INS1ZJ 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  • Withdrawn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 · synced 24 Oct 2026

Device Name
SOL-M Insulin Syringe with Fixed Needle
Model / Reference
Insulin Standard Syringe with fixed needle, 161311564B
Primary DI / UDI-DI
00818392016574
Basic UDI-DI
081006243INS1ZJ
Direct Marketing DI
00818392016574
EMDN Code
A02010601 Insulin syringes with fixed needle, 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.

See all devices from Sol-Millennium Medical, Inc. →

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 00818392016574|081006243INS1ZJ 61 fields · synced 24 Oct 2026