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HANAROSTENT® Esophagus Upper (CCC) ECP20100-X070

by M.I.Tech Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809867585178 UDI-DI Date23 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
HANAROSTENT® Esophagus Upper (CCC)
Generic Name
Polymer-metal oesophageal stent
Model / Reference
ECP20100-X070
Primary DI / UDI-DI
08809867585178
510(k) Number
FDA Product Code
ESW
GMDN Term
Polymer-metal oesophageal stent
Device Class
Class II
Regulation Number
878.3610
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Stent Diameter — 20 Millimeter
Stent Length — 100 Millimeter

Related devices

Cleared under the same submission (K253327)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (6)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No