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DK Score Pro Coronary Scoring Balloon Dilatation Catheter

by DK Medical Technology Co., Ltd. EUDAMED

Active European Union

Ref CSL-2215

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69722536014CSL5K Basic UDI-DIDate25 Feb 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  • Withdrawn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)
  • M.2025.MDR.1062-1 Withdrawn

    Technical documentation EU MDR

    Notified body
    UDEM Adriatic d.o.o. 2696
    Issued
    18 Feb 2025
    Expires
    17 Feb 2028
    Reason
    Other

Specification

EUDAMED

Device Name
Coronary Scoring Balloon Dilatation Catheter
Model / Reference
CSL-2215
Primary DI / UDI-DI
06923533800821
Basic UDI-DI
69722536014CSL5K
EMDN Code
C010401020199 Ptca dilatation catheters - other
Device Class
Class III
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000011218
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from DK Medical Technology Co., Ltd.

See all devices from DK Medical Technology Co., Ltd. →

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