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Vara PACS

by MX Healthcare GmbH Germany EUDAMED

Ref 1.X EMDN Z11030282

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426073218VaraPACSX8 Basic UDI-DIDate27 Nov 2023RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
1.X
Primary DI / UDI-DI
04260732180012
Basic UDI-DI
426073218VaraPACSX8
EMDN Code
Z11030282 Mammography systems - software accessories
Device Class
Class I
Special Device Type
Software

Manufacturer details

EUDAMED SRN
DE-MF-000006986

Other devices from MX Healthcare 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 (1)

  • EUDAMED bd939300-d94a-40e7-a522-a44940a1134e 61 fields · synced 24 Oct 2026