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Pts

by Sorin Group Italia S.r.L. United States EUDAMED

Ref 082276

EMDN C03010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08033178227117 Basic UDI-DIDate17 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
082276 De Jena
Model / Reference
082276
Primary DI / UDI-DI
08033178227117
Basic UDI-DI
B-08033178227117
EMDN Code
C03010101 Extracorporeal circulation circuits
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000027510

Other devices from Sorin Group Italia S.R.L

See all devices from Sorin Group Italia S.R.L →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 08033178227117|B-08033178227117 61 fields · synced 24 Oct 2026