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Solojekt

by I'M Medicare SARL 72 variants

Ref IT-09-22-LLModel 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number611800222HYPOSRGGD Basic UDI-DI 06118002222253UDI-DIDate22 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  • Withdrawn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
Hypodermic Syringe
Model / Reference
SOLOJEKT, IT-09-22-LL
Primary DI / UDI-DI
06118002222253
Basic UDI-DI
611800222HYPOSRGGD
EMDN Code
A020199 Syringes, single-use - other
Device Class
Class IIa
EU market of registration
France

Manufacturer details

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

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    Class I

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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