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Colonic/Rectal Stent with Delivery System

by M.I.Tech Co., Ltd EUDAMED

Active European Union

Ref NCS-22-070-230Model HANAROSTENT® Colon/Rectum (NNN)

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88063670COLN001Q4 Basic UDI-DIDate4 Sep 2026RegisteredStatusActive

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  • Withdrawn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)
  • G70 080984 0025 Supplemented

    Technical documentation EU MDR

    Notified body
    TÜV SÜD Product Service GmbH 0123
    Issued
    9 Jul 2026
    Expires
    30 Aug 2028
    Reason
    Add device or group

Specification

EUDAMED

Device Name
Colonic/Rectal Stent with Delivery System
Model / Reference
HANAROSTENT® Colon/Rectum (NNN), NCS-22-070-230
Primary DI / UDI-DI
08806367069689
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000011623
Authorised representative
KTR Europe GmbH DE-AR-000005685

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