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INFINITI™ Diagnostic Catheter/SUPER TORQUE™ Diagnostic Catheter/SUPER TORQUE™ Plus Diagnostic Catheter/TEMPO™ AQUA Diagnostic Catheter

by Cordis US Corp. EUDAMED

Active European Union

Ref SR3448

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number07050320000000000000052CL Basic UDI-DIDate29 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 771918 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    1 Jun 2026
    Expires
    7 Jul 2029
    Reason
    Add device or group

Specification

EUDAMED

Model / Reference
SR3448
Primary DI / UDI-DI
10705032062633
Basic UDI-DI
07050320000000000000052CL
EMDN Code
C0104010101,C0104020101
Device Class
Class III
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000020031
Authorised representative
Cordis Cashel IE-AR-000017793

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Properties

Show properties
  • Sterile
Other properties (12)
  • 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