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Khelix Decapolar Steerable Electrophysiology Catheter

by CathRx Ltd 3 variants

Ref SS1-D0U-10A6252Model Diagnostic Steerable Electrophysiology Catheter

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09351351000043 Basic UDI-DI 09351351000043UDI-DIDate16 Jul 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

Germany
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

EU market availability

Made available in 1 country, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Germany since 1 Sep 2025

Last checked 30 Oct 2026.

Specification

EUDAMED

Device Name
Khelix Decapolar Steerable Electrophysiology Catheter [SS1-D0U-10A6252]
Model / Reference
Diagnostic Steerable Electrophysiology Catheter, SS1-D0U-10A6252
Primary DI / UDI-DI
09351351000043
Basic UDI-DI
B-09351351000043
EMDN Code
C02010403 Arrhythmology multipolar diagnostic catheters, adjustable
Device Class
Class III
EU market of registration
Germany

Manufacturer details

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

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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