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Khelix Decapolar Fixed Loop Steerable Electrophysiology Catheter

by CathRx Ltd EUDAMED

Active European Union

Ref SC1-B15U-10P7555Model Diagnostic Loop Steerable Electrophysiology Catheter

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09351351000074 Basic UDI-DIDate16 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Khelix Decapolar Fixed Loop Steerable Electrophysiology Catheter [SC1-B15U-10P7555]
Model / Reference
Diagnostic Loop Steerable Electrophysiology Catheter, SC1-B15U-10P7555
Primary DI / UDI-DI
09351351000074
Basic UDI-DI
B-09351351000074
EMDN Code
C02010403 Arrhythmology multipolar diagnostic catheters, adjustable
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
AU-MF-000002757
Authorised representative
Advena Limited MT-AR-000000234

Other devices from CathRx, Ltd.

See all devices from CathRx, Ltd. →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No