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SOL-M Insulin Syringe with Fixed Needle

by Sol-Millennium Medical, Inc.

Ref 1613151, 1613051, 1653051, 1653151Model Insulin Standard Syringe with fixed needle

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081006243INS1ZJ Basic UDI-DI Date8 Jan 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Insulin Standard Syringe with fixed needle, 1613151, 1613051, 1653051, 1653151
Primary DI / UDI-DI
00818392017458, 00818392017366, 00818392017359, 00818392017441
Basic UDI-DI
081006243INS1ZJ
Direct Marketing DI
00818392017458
00818392017366
00818392017359
00818392017441
EMDN Code
A02010601 Insulin syringes with fixed needle, single-use
Device Class
Class IIa
EU 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

  • 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