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Awario Gem

by Heart2Save Oy Finland EUDAMED

Ref 4010

EMDN C020501

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number64298105834010UN Basic UDI-DIDate2 Dec 2021RegisteredStatusActive

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
Awario Gem Silver/Black
Model / Reference
4010
Primary DI / UDI-DI
06429810583055
Basic UDI-DI
64298105834010UN
Direct Marketing DI
06429810583055
EMDN Code
C020501 ECG electrodes
Device Class
Class I
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 (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 11fa1530-cd4a-407a-ab59-a8baa6e50a0d 61 fields · synced 22 Oct 2026