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Kulani™ NC

by Meril Life Sciences Pvt. Ltd. EUDAMED

Active European Union

Ref KNM20010

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-18904224942513 Basic UDI-DIDate25 Jul 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Kulani™ NC - Rx PTCA Balloon Dilatation Catheter
Model / Reference
KNM20010
Primary DI / UDI-DI
18904224942513
Basic UDI-DI
B-18904224942513
EMDN Code
C010401020101 Ptca balloon dilation catheters
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
IN-MF-000008308
Authorised representative
Obelis s.a. BE-AR-000000106

Related devices

Category: Coronary angioplasty balloon catheter, cutting/scoring

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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