Skip to content

iCONNECT - SMARTABLATE

by OSYPKA GmbH Germany EUDAMED

Ref 001-009076-1Model iCONNECT System Cable

EMDN C020399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4044508iConnectSCS Basic UDI-DIDate26 May 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
iCONNECT System Cable, 001-009076-1
Primary DI / UDI-DI
04044508137000
Basic UDI-DI
4044508iConnectSCS
EMDN Code
C020399 Cardiac tissue ablation devices - other
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005610

Other devices from Osypka AG

See all devices from Osypka AG →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • 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
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED f475276b-5c1b-4a7a-9dbf-5365a20f2427 61 fields · synced 24 Oct 2026