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XPS™ Disposable Lung Kit

by XVIVO Perfusion AB United States EUDAMED

Ref 19094

EMDN C0399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number735006952000IYU Basic UDI-DIDate6 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Disposable Lung Kits
Model / Reference
19094
Primary DI / UDI-DI
07350069520524
Basic UDI-DI
735006952000IYU
EMDN Code
C0399 Cardiosurgery and organ transplantation devices - other
Device Class
Class III
Medical Purpose
The ingoing devices in XVIVO Disposable Lung Kit and XPS Disposable Lung Kit are intended to be combined in “kits” to achieve the Intended Purpose of the XVIVO Perfusion System (XPS)

Manufacturer details

EUDAMED SRN
SE-PR-000018118

Other devices from Xvivo Perfusion Ab

Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED 10630f46-06d1-4aff-9e17-8d965d8191a2 61 fields · synced 22 Oct 2026