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ComfortFine

by Pikdare S.p.A. Italy EUDAMED

Ref 58014300403000Model PEN NEEDLE

EMDN A0101010202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8058090PN310000ES Basic UDI-DIDate16 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
PEN NEEDLE, 58014300403000
Primary DI / UDI-DI
18058090055775
Basic UDI-DI
8058090PN310000ES
EMDN Code
A0101010202 Hypodermic pen needles, w/o safety systems
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000010069

Other devices from Pikdare S.p.A.

See all devices from Pikdare S.p.A. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Administering Medicine
Other properties (11)
  • 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

Sources (1)

  • EUDAMED 65fa0944-acc8-450d-9bb2-9df4f2d43798 61 fields · synced 24 Oct 2026