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XVIVO Heart Solution Supplement™

by XVIVO Perfusion AB United States EUDAMED

Ref 19405

EMDN C0399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number735006952000LZ2 Basic UDI-DIDate1 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • C765192 Issued

    Technical documentation EU MDR

    Notified body
    DNV Product Assurance AS 2460
    Issued
    11 Aug 2026
    Expires
    10 Aug 2031

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
19405
Primary DI / UDI-DI
07350069520586
Basic UDI-DI
735006952000LZ2
EMDN Code
C0399 Cardiosurgery and organ transplantation devices - other
Device Class
Class III
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000018108

Other devices from Xvivo Perfusion Ab

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Incorporates Medicinal Product
Other properties (11)
  • 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

Sources (1)

  • EUDAMED 07350069520586|735006952000LZ2 61 fields · synced 23 Oct 2026