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Sterile Hypodermic Needle 16GX1''

by I'M Medicare SARL 53 variants

Ref IT-00-03-BNModel SOLOJEKT HYPODERMIC

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number611800222HYPONDLEL Basic UDI-DI 06118002223137UDI-DIDate21 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  • Withdrawn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 Hypodermic Needle 16GX1''
Model / Reference
SOLOJEKT HYPODERMIC, IT-00-03-BN
Primary DI / UDI-DI
06118002223137
Basic UDI-DI
611800222HYPONDLEL
EMDN Code
A0101010102 Hypodermic syringe 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

From the manufacturer

Manufacturer's product page: Hypodermic Needles

Other devices from I'M Medicare SARL

  • Solojekt

    Class I

  • Sterile Hypodermic Needle 16GX1''

    Class IIa

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    Class IIa

  • Slolojekt Ad

    Class IIa

  • Solojekt

    Class I

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See all devices from I'M Medicare SARL →

Properties

  • Administering Medicine

Other properties (12)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No