Skip to content

Heartfelt-4 device

by Heartfelt Technologies Ltd United Kingdom EUDAMED

Ref N/AModel Home

EMDN Z12040199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08600068129HF-3FW Basic UDI-DIDate20 Mar 2023RegisteredStatusActive

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
Hf-3
Model / Reference
Home, N/A
Primary DI / UDI-DI
00860006812928
Basic UDI-DI
08600068129HF-3FW
EMDN Code
Z12040199 General medicine diagnosis and monitoring instruments - other
Device Class
Class IIa
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000020340
Authorised representative
Heartfelt Technologies Europe Ltd IE-AR-000004263

Other devices from Heartfelt Technologies Ltd

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 (1)

  • EUDAMED cc0891fa-e306-4541-a81b-4ae2c2817236 61 fields · synced 22 Oct 2026