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Solojekt

by I'M Medicare SARL 72 variants

Ref IT-20-45-00Model SOLOJEKT

Active European Union

CE MDR

Valid until

19 Jan 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number611800222SYRINSBL Basic UDI-DI 06118002224325UDI-DIDate23 Apr 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Sterile Insulin Syringe
Model / Reference
SOLOJEKT, IT-20-45-00
Primary DI / UDI-DI
06118002224325
Basic UDI-DI
611800222SYRINSBL
EMDN Code
A0101010202 Hypodermic pen needles, w/o safety systems
Device Class
Class IIa
EU 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

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    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

  • 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