Skip to content

CardiolyseECGSoftware

by Cardiolyse Oy 2 variants

Ref CardiolyseECGSoftware

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-CardiolyseECGsoftwareBH Basic UDI-DI D-CardiolyseECGsoftwareBHUDI-DIDate14 Oct 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
CardiolyseECGSoftware
Primary DI / UDI-DI
D-CardiolyseECGsoftwareBH
Basic UDI-DI
B-CardiolyseECGsoftwareBH
EMDN Code
Z12030682
Device Class
Class IIa
Special Device Type
-1192
EU market of registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000017174

Other devices from Cardiolyse Oy

Properties

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