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LUNGguard

by Paragonix Technologies, Inc. United States EUDAMED

Ref 408

EMDN A0999

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number850005470SHRPF9L Basic UDI-DIDate4 Aug 2025RegisteredStatusActive

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
SherpaPak Family of Devices
Model / Reference
408
Primary DI / UDI-DI
10850005470189
Basic UDI-DI
850005470SHRPF9L
EMDN Code
A0999 Organ preservation solutions and containers - other
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000038585
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Paragonix Technologies, Inc.

See all devices from Paragonix Technologies, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • Sterile: No
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED f85a1cc1-4a43-446a-bf14-3d1bd49fb960 61 fields · synced 22 Oct 2026