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Awario Analysis Service

by Heart2Save Oy Finland EUDAMED

Ref 1010

EMDN Z12050392

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06429810583000 Basic UDI-DIDate2 Dec 2021RegisteredStatusActive

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
1010
Primary DI / UDI-DI
06429810583000
Basic UDI-DI
B-06429810583000
EMDN Code
Z12050392 Electrocardiographs - medical device software
Device Class
Class IIa
Special Device Type
-1192
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000004794

Other devices from Heart2Save Oy

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 50786c3a-9765-4b21-a5f8-9a2401204000 61 fields · synced 22 Oct 2026