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CardioLinks

by SynexCare sp. z o.o. Poland EUDAMED

Ref 10051000

EMDN Z12050480

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number590547178901005QH Basic UDI-DIDate15 Jan 2026RegisteredStatusActive

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
Przyłącze kablowe do rejestratora holterowskiego
Model / Reference
10051000
Primary DI / UDI-DI
05905471789049
Basic UDI-DI
590547178901005QH
Direct Marketing DI
05905471789049
EMDN Code
Z12050480 Holter system instruments for cardiovascular parameters - hardware accessories
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000038028

Other devices from SynexCare sp. z o.o.

  • CardioNotes

    Class IIb

  • CardioWaver

    Class IIa

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 a9143515-692c-4906-8c99-3db728674d7a 61 fields · synced 22 Oct 2026