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PL2LUNGP3D - Sistema di rimozione extracorporea di CO2 a bassi flussi (LF-ECCO2R) per ESTORFLOW (SBF) – durata 3 giorni

by Estor SpA

Ref PL2LUNGP3D

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805604529KITPROLUNGS2 Basic UDI-DI 08056045290106UDI-DIDate18 Oct 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
ProLUNG 3D for Aquarius System - Low-flow extracorporeal CO2 partial removal system - 3 days
Model / Reference
PL2LUNGP3D
Primary DI / UDI-DI
08056045290106
Basic UDI-DI
805604529KITPROLUNGS2
EMDN Code
C03010199 Extracorporeal circulation kits - other
Device Class
Class IIa
Medical Purpose
ProLUNG® 3D CO2 removal device is intended for use in a veno-venous extracorporeal circulation system for blood CO2 partial removal in patients with acute respiratory failure. LF- ECCO2R support is an extracorporeal circulation technique used to temporarily assist the pulmonary functions in gaseous exchange of primarily carbon dioxide and partly oxygen. This technique can be applied to patients affected by acute respiratory failure not manageable with the sole aid of mechanical ventilation (pulmonary ventilator).

Manufacturer details

EUDAMED SRN
IT-PR-000037791

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Properties

Other properties (1)

  • Sterile: No