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EnSite™

by Abbott Medical Ireland EUDAMED

Ref ENSITE-ECGRL-I-01 EMDN Z12059080

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5414734DMC0038CU Basic UDI-DIDate9 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
EnSite X EP System Accessories
Model / Reference
ENSITE-ECGRL-I-01
Primary DI / UDI-DI
05415067033529
Basic UDI-DI
5414734DMC0038CU
EMDN Code
Z12059080 Various instruments for cardiology and cardiac surgery - hardware accessories
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000033655
Authorised representative
Abbott Medical BE-AR-000008744

Other devices from Abbott Medical

See all devices from Abbott Medical →

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 05415067033529|5414734DMC0038CU 61 fields · synced 25 Oct 2026