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Hanarostent®

by M.I.Tech Co., Ltd EUDAMED

Active European Union

Ref BCS10060-R060Model HANAROSTENT® Biliary Flap (CCC)

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08806367086891 Basic UDI-DIDate2 Aug 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  • Withdrawn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
Biliary Stent with Delivery System
Model / Reference
HANAROSTENT® Biliary Flap (CCC), BCS10060-R060
Primary DI / UDI-DI
08806367086891
Basic UDI-DI
B-08806367086891
EMDN Code
P0502 Biliary and pancreatic prostheses
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

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

Other devices from M.I.Tech Co., Ltd.

See all devices from M.I.Tech Co., Ltd. →

Properties

Show properties
  • Sterile
  • Implantable
Other properties (9)
  • 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