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Beat2Phone ECG Service

by VitalSignum Oy EUDAMED

Active European Union

Ref Beat2Phone ECG Service

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-Beat2PhoneEcgService6X Basic UDI-DIDate4 Jan 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Beat2Phone ECG Service
Model / Reference
Beat2Phone ECG Service
Primary DI / UDI-DI
D-Beat2PhoneEcgService6X
Basic UDI-DI
B-Beat2PhoneEcgService6X
EMDN Code
Z12059009 ECG data management systems
Device Class
Class IIa
Special Device Type
-1192
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000010423

Other devices from VitalSignum Oy

Properties

  • Measuring Function

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No