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Hanarostent®

by M.I.Tech Co., Ltd EUDAMED

Active European Union

Ref HESV-22-060-070Model HANAROSTENT® Esophagus Valve (CCC)

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08806367041043 Basic UDI-DIDate3 Aug 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Esophageal Stent with Delivery System
Model / Reference
HANAROSTENT® Esophagus Valve (CCC), HESV-22-060-070
Primary DI / UDI-DI
08806367041043
Basic UDI-DI
B-08806367041043
EMDN Code
P050101 Gastro-esophageal reflux correction 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

  • 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