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EnSite™

by Abbott Medical Costa Rica Ltda. EUDAMED

Active European Union

Ref ENSITE-SEK-5-I-01

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5414734DMS0041HZ Basic UDI-DIDate28 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
EnSite X EP System Surface Electrodes
Model / Reference
ENSITE-SEK-5-I-01
Primary DI / UDI-DI
05415067032386
Basic UDI-DI
5414734DMS0041HZ
EMDN Code
Z12059085 Various instruments for cardiology and cardiac surgery - consumables
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
CR-MF-000044527
Authorised representative
Abbott Medical BE-AR-000008744

Other devices from Abbott Medical Costa Rica Ltda.

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