Skip to content

ECG247

by Appsens AS Norway EUDAMED

Ref 4

EMDN Z12050492

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number709005222ECG247SOFTWAREWN Basic UDI-DIDate6 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
ECG247 Software Solution
Model / Reference
4
Primary DI / UDI-DI
07090052220047
Basic UDI-DI
709005222ECG247SOFTWAREWN
Direct Marketing DI
07090052220047
EMDN Code
Z12050492 Holter system instruments for cardiovascular parameters - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Norway

Manufacturer details

EUDAMED SRN
NO-MF-000013438

Other devices from Appsens AS

See all devices from Appsens AS →

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 (1)

  • EUDAMED 6632d430-d716-46df-944a-8927af02b487 61 fields · synced 22 Oct 2026