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RenalGuard Console

by CardioRenal Systems, Inc. United States EUDAMED

Ref FM1

EMDN A03010105

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00866379000122 Basic UDI-DIDate10 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
FM1
Primary DI / UDI-DI
00866379000122
Basic UDI-DI
B-00866379000122
EMDN Code
A03010105 Infusion pump controllers
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000035063
Authorised representative
RenalGuard Solutions EU GmbH DE-AR-000020280

Other devices from CardioRenal Systems, Inc.

Properties & raw data

Show properties, registry sources and raw records
  • Administering Medicine
  • Measuring Function
Other properties (9)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 9719b857-9918-4ad5-9a1f-1019df9d96be 61 fields · synced 22 Oct 2026