Skip to content

XPS™ Disposable Lung Kit

by XVIVO Perfusion AB United States EUDAMED

Ref 19091

EMDN C0399

Regulatory status

as of 25 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 23 Oct 2026

Device Name
Disposable Lung Kits
Model / Reference
19091
Primary DI / UDI-DI
07350069520517
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

See all devices from Xvivo Perfusion Ab →

Properties & raw data

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

Sources (1)

  • EUDAMED 698be132-35d3-4b4f-b3f1-95efe86826ae 61 fields · synced 23 Oct 2026