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Duodenal/Pyloric Stent with Delivery System

by M.I.Tech Co., Ltd 455 variants

Ref DNNS-20-110-120Model HANAROSTENT® Naturfit™ Duodenum/Pylorus (NNN)

Active European Union

CE MDR

Valid until

30 Aug 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88063670DUON006UE Basic UDI-DI 08806367077387UDI-DIDate22 Sep 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 080984 0025 Active Supplemented

    Technical documentation EU MDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    9 Jul 2026
    Expires
    30 Aug 2028
    Reason
    Add device or group

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Duodenal/Pyloric Stent with Delivery System
Model / Reference
HANAROSTENT® Naturfit™ Duodenum/Pylorus (NNN), DNNS-20-110-120
Primary DI / UDI-DI
08806367077387
Basic UDI-DI
88063670DUON006UE
EMDN Code
P0503 Colonic and duodenal prostheses
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000011623
Authorised representative
KTR Europe GmbH DE-AR-000005685

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Properties

  • Sterile
  • Implantable

Other properties (12)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No