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CardioSignal

by Precordior Oy Finland EUDAMED

Ref Android v. 3.1, CardioSignal, iOS v. 3.1

EMDN Z12050892

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number643008145CSAFIB3Y Basic UDI-DIDate7 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Android v. 3.1, CardioSignal, iOS v. 3.1
Primary DI / UDI-DI
06430081450069, D-CardioSignalXP, 06430081450052
Basic UDI-DI
643008145CSAFIB3Y, B-CardioSignalXP
Direct Marketing DI
06430081450069
06430081450052
EMDN Code
Z12050892 Cardiac telemetry instruments - medical device software
Device Class
Class IIb
Class IIa
Special Device Type
Software
-1192
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000014540

Other devices from Precordior Oy

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 (3)

  • EUDAMED 5a5dde80-a815-4890-9631-8c15c490f9e7 61 fields · synced 24 Oct 2026
  • EUDAMED D-CARDIOSIGNALXP|B-CARDIOSIGNALXP 61 fields · synced 18 May 2026
  • EUDAMED 06430081450052|643008145CSAFIB3Y 61 fields · synced 18 May 2026