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HeartSave Y1 and Accs.

by Metrax GmbH EUDAMED

Active European Union

Ref 97883

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberG70 023787 0036 Date17 Mar 2025IssuedStatusActive expires 16 Mar 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED

Device Name
HeartSave Y
Model / Reference
97883
Primary DI / UDI-DI
04260648814292
Basic UDI-DI
426064881HSYKJ
EMDN Code
Z12030501 Semi-automatic defibrillators
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005478

Other devices from Metrax GmbH

See all devices from Metrax GmbH →

Properties

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