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Inspire

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

Ref 050728J

EMDN C03010102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8033178OXYINSPCZ Basic UDI-DIDate28 Jul 2026RegisteredStatusWithdrawn Not intended for 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  • Withdrawn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European Union — CE/MDR Withdrawn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

Device Name
Oxygenators
Model / Reference
050728J
Primary DI / UDI-DI
08033178113243
Basic UDI-DI
8033178OXYINSPCZ
EMDN Code
C03010102 Oxygenator kits
Device Class
Class IIa

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 (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 9dd9f07d-9b29-47f1-80f1-3b85d8ca0fe6 61 fields · synced 24 Oct 2026