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Solojekt

by I'M Medicare SARL EUDAMED

Active European Union

Ref IT-10-00-BSModel SOLOJEKT BULK

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number611800222SRGBLK4Z Basic UDI-DIDate7 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED

Device Name
Class I devices with a measuring function
Model / Reference
SOLOJEKT BULK, IT-10-00-BS
Primary DI / UDI-DI
06118002224813
Basic UDI-DI
611800222SRGBLK4Z
Unit of Use DI
16118002224810
EMDN Code
A020199 Syringes, single-use - other
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
MA-MF-000037665
Authorised representative
EUCEREP B.V. NL-AR-000001966

Other devices from I'M Medicare SARL

  • Solojekt

    Class I

  • Sterile Hypodermic Needle 16GX1''

    Class IIa

  • Solojekt Ad

    Class IIa

  • Slolojekt Ad

    Class IIa

  • Solojekt

    Class I

  • Solojekt

    Class I

See all devices from I'M Medicare SARL →

Properties

  • Administering Medicine
  • Measuring Function

Other properties (11)

  • Sterile: No
  • 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