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Khelix Quadpolar Fixed Electrophysiology Catheter

by CathRx Ltd

Ref 5SSF-ANN-4A555Model Diagnostic Fixed 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-09351351001163 Basic UDI-DI 09351351001163UDI-DIDate20 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

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Khelix Quadpolar Fixed Electrophysiology Catheter [5SSF-ANN-4A555]
Model / Reference
Diagnostic Fixed Electrophysiology Catheter, 5SSF-ANN-4A555
Primary DI / UDI-DI
09351351001163
Basic UDI-DI
B-09351351001163
EMDN Code
C02010401 Arrhythmology multipolar diagnostic catheters, conventional
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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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