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PLLUNG3D - System for low-flow extracorporeal CO2 removal (LF-ECCO2R) – 3 days duration

by Estor SpA EUDAMED

Active European Union

Ref PLLUNG3D

Regulatory status

as of 26 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
ProLUNG 3D for Aquarius System - Low-flow extracorporeal CO2 partial removal system - 3 days
Model / Reference
PLLUNG3D
Primary DI / UDI-DI
08056045290052
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

Other devices from Estor SpA

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Properties

Show properties
Other properties (1)
  • Sterile: No