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IscAlert Introducer

by Sensocure As Norway EUDAMED

Ref 80007

EMDN C0503

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number709006232ISCALERTINTROVR Basic UDI-DIDate12 Feb 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
80007
Primary DI / UDI-DI
07090062320034
Basic UDI-DI
709006232ISCALERTINTROVR
Direct Marketing DI
07090062320034
EMDN Code
C0503 Cardiovascular introducer sheaths, peel-away
Device Class
Class IIa
Market of Registration
Norway

Manufacturer details

EUDAMED SRN
NO-MF-000031688

Other devices from Sensocure As

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED ac876f93-b8b3-40e7-b618-b1aa9495de4c 61 fields · synced 22 Oct 2026