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x-cardiac-platform

by Asclea GmbH EUDAMED

Active European Union

Ref REF1

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberZ-22-151-S-IX Date14 Oct 2025IssuedStatusActive expires 19 Sep 2029

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • Z-22-151-S-IX Active

    Quality management system EU MDR

    Notified body
    Berlin Cert GmbH 0633
    Issued
    14 Oct 2025
    Expires
    19 Sep 2029

Specification

EUDAMED

Device Name
x-cardiac-platform
Model / Reference
REF1
Primary DI / UDI-DI
04260752980012
Basic UDI-DI
426075298xcp01YC
Direct Marketing DI
04260752980012
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000007826

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