Skip to content

Preventicus Heartbeats App

by Preventicus GmbH Germany EUDAMED

Ref HB iOS

EMDN C020599

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number409996600000GK Basic UDI-DIDate11 Jun 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

Device Name
Preventicus Heartbeats & Preventicus Nightwatch
Model / Reference
HB iOS
Primary DI / UDI-DI
04099966000182, 04099966000243
Basic UDI-DI
409996600000GK
Direct Marketing DI
04099966000182
04099966000243
EMDN Code
C020599 Cardiac diagnostic devices - other
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Germany
Austria

Manufacturer details

EUDAMED SRN
DE-MF-000008931

Other devices from Preventicus GmbH

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED cf1c7c58-0dac-4314-bc23-2a0fb5e9e2db 61 fields · synced 24 Oct 2026
  • EUDAMED 04099966000243|409996600000GK 61 fields · synced 20 Oct 2026