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Hanarostent®

by M.I.Tech Co., Ltd 107 variants

Ref ECBA-20-150-230Model HANAROSTENT® Esophagus TTS (CCC)

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08806367032058 UDI-DI Date20 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-08806367032058 Basic UDI-DI 08806367032058UDI-DIDate17 Aug 2026RegisteredStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Hanarostent® EUDAMED
HANAROSTENT® Esophagus TTS(CCC) GUDID
Generic Name
Polymer-metal oesophageal stent
Device Name
Esophageal Stent with Delivery System
Model / Reference
HANAROSTENT® Esophagus TTS (CCC), ECBA-20-150-230
Primary DI / UDI-DI
08806367032058
Basic UDI-DI
B-08806367032058
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
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Stent Diameter — 20 Millimeter
Stent Length — 150 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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

  • 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