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HANAROSTENT® Esophagus TTS(NCN) EPBA-20-100-230

by M.I.Tech Co., Ltd.

Ref EPBA-20-100-230Model HANAROSTENT® Esophagus TTS (NCN)

Active European Union. Also listed in GUDID (US), partly in commercial distribution.

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
European UnionCE/MDD EUDAMED NumberB-08806367072023 Basic UDI-DI 08806367072023UDI-DIDate2 Aug 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number08806367072023 UDI-DI Date29 May 2020ListedStatusListed GUDID: 1 of 2 UDI-DIs in commercial distribution

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  • Withdrawn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(NCN) GUDID
Generic Name
Polymer-metal oesophageal stent
Device Name
Esophageal Stent with Delivery System
Model / Reference
EPBA-20-100-230, HANAROSTENT® Esophagus TTS (NCN)
Primary DI / UDI-DI
08806367072023, 08806367088895
Basic UDI-DI
B-08806367072023
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
Not in Commercial Distribution (UDI-DI 08806367088895)
In Commercial Distribution (UDI-DI 08806367072023)
MRI Safety
MR Conditional
Size
Stent Diameter — 20 Millimeter
Stent Length — 100 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

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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