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CardiRisk

by Predilife France EUDAMED

Ref CardiRisk

EMDN Z12040182

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-03701126500067 Basic UDI-DIDate19 May 2022RegisteredStatusActive

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
CardiRisk
Primary DI / UDI-DI
03701126500067
Basic UDI-DI
B-03701126500067
EMDN Code
Z12040182 General medicine diagnosis and monitoring instruments - software accessories
Device Class
Class I
Special Device Type
-1192
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000001863

Other devices from Predilife

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED b1df1eaa-926d-4723-ba37-1d0b50d398cc 61 fields · synced 22 Oct 2026