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Iris

by Gergonne Industrie France EUDAMED

Ref PADIRIS-2

EMDN M030404

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0370148760199904048D Basic UDI-DIDate12 Jan 2024RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
PADIRIS-2
Primary DI / UDI-DI
03701487600055
Basic UDI-DI
0370148760199904048D
Unit of Use DI
03701487600116
EMDN Code
M030404 Dialysis fistula, bandages
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000003647

Other devices from Gergonne Industrie

See all devices from Gergonne Industrie →

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 38b5f178-e853-41c4-8256-e532e59325ab 61 fields · synced 24 Oct 2026