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Hanarostent®

by M.I.Tech Co., Ltd South Korea EUDAMEDGUDID

Ref ECP20120-X070Model HANAROSTENT® Esophagus Upper (CCC)

Product code ESWEMDN P050199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08806367044327 UDI-DIDate23 Dec 2025ListedStatusIn distribution
European UnionCE/MDD EUDAMED NumberB-08806367044327 Basic UDI-DIDate2 Aug 2022RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Listed
  • Not covered
  • European Union CE/MDD Expiring (legacy directive)
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Trade Name
Hanarostent® EUDAMED
HANAROSTENT® Esophagus Upper (CCC) GUDID
Generic Name
Polymer-metal oesophageal stent
Device Name
Esophageal Stent with Delivery System
Model / Reference
HANAROSTENT® Esophagus Upper (CCC), ECP20120-X070
Primary DI / UDI-DI
08806367044327 EUDAMED
08809867585192 GUDID
Basic UDI-DI
B-08806367044327
510(k) Number
FDA Product Code
ESW
EMDN Code
P050199 Esophageal prostheses - other
GMDN Term
Polymer-metal oesophageal stent
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.3610
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Conditional
Size
Stent Diameter — 20 Millimeter
Stent Length — 120 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
08806367044327
GUDID
08809867585192
Device ClassEUDAMED
Class IIb
GUDID
Class II

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 & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date
Other properties (14)
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No

Sources (2)

  • EUDAMED 80594c92-6477-45de-b2b3-bbb8d9a066bf 61 fields · synced 23 Oct 2026
  • FDA UDI c04bd15a-4f7f-4061-ab61-68a72db1103d 37 fields · synced 23 Oct 2026