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Xtra

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

Ref 04315J

EMDN B0480

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8033178CARDATSSEQSL Basic UDI-DIDate23 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  • Withdrawn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European Union — CE/MDR Withdrawn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
Autotransfusion
Model / Reference
04315J
Primary DI / UDI-DI
08033178114899
Basic UDI-DI
8033178CARDATSSEQSL
EMDN Code
B0480 Autotransfusion devices - accessories
Device Class
Class IIb

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 48baf562-bf72-46eb-8fac-2941c8041fc9 61 fields · synced 24 Oct 2026