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Hanarostent®

by M.I.Tech Co., Ltd 831 variants

Ref TLC-22-060-230Model HANAROSTENT® TwynLay™ Colon/Rectum (NCN)

Active European Union

CE MDR CE MDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberG70 080984 0025 Date9 Jul 2026IssuedStatusActive expires 30 Aug 2028
European UnionCE/MDD NumberB-08806367050335 Basic UDI-DI 08806367050335UDI-DIDate5 Aug 2022RegisteredStatusActive

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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Device Name
Colon/Rectum Stent with Delivery System
Colonic/Rectal Stent with Delivery System
Model / Reference
HANAROSTENT® TwynLay™ Colon/Rectum (NCN), TLC-22-060-230
Primary DI / UDI-DI
08806367050335
Basic UDI-DI
B-08806367050335, 88063670COLC007N3
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

Other devices from M.I.Tech Co., Ltd.

See all devices from M.I.Tech Co., Ltd. →

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