Skip to content

Hanarostent®

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

Ref BNHS-06-100-180Model HANAROSTENT® Benefit™ Biliary (NNN)

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 22 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08806367064400 Basic UDI-DI Date3 Aug 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number08806367064400 UDI-DI Date31 Aug 2021ListedStatusListed GUDID: 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 22 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  • Withdrawn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® Benefit™ Biliary (NNN) GUDID
Generic Name
Bare-metal biliary stent
Device Name
Biliary Stent with Delivery System
Model / Reference
HANAROSTENT® Benefit™ Biliary (NNN), BNHS-06-100-180
Primary DI / UDI-DI
08806367064400 EUDAMED
08806367075703 EUDAMED
08806367092861 GUDID
Basic UDI-DI
B-08806367064400, B-08806367075703
510(k) Number
FDA Product Code
FGE
EMDN Code
P0502 Biliary and pancreatic prostheses
GMDN Term
Bare-metal biliary stent
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.5010
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Stent Diameter — 6 Millimeter
Stent Length — 100 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
08806367064400
08806367075703
GUDID
08806367092861
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
  • Administering Medicine NoEUDAMEDYesEUDAMED
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (13)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No