BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    M.I.Tech Co., Ltd.

    Reg #: 3011458193 · FEI: 3011458193 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    M.I.Tech Co., Ltd.
    Registration Number
    3011458193
    FEI Number
    3011458193
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    458, Bongeunsa-ro, Gangnam-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K190141

    Owner / Operator

    Firm Name
    M.I.Tech Co., Ltd.
    Operator Number
    10030918
    Address
    174, habuk 2gil, jinwimyeon
    City
    Pyeongtaek
    State
    Gyeonggi
    Postal Code
    17706
    Country
    KR
    Correspondent
    Jaioh Kwak

    US Agent

    Business Name
    LK Consulting Group USA, Inc.
    Contact Name
    Priscilla Chung
    Address
    2552 Walnut Ave Ste 230
    City
    Tustin
    State
    CA
    ZIP
    92780
    Country
    US
    Email
    [email protected]
    Phone
    714 9225276

    Products

    Device Name Product Code
    Stent, Colonic, Metallic, Expandable MQR
    Prosthesis, Esophageal ESW
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Stent, Metallic, Expandable, Duodenal MUM
    Prosthesis, Tracheal, Expandable JCT

    Proprietary Names

    HANAROSTENT LowAX Colon/Rectum(NNN) HANAROSTENT LowAx Duodenum/Pylorus(NNN) HANAROSTENT® Esophagus (CCC), HANAROSTENT® Esophagus (NCN) HANAROSTENT Esophagus Upper (CCC) HANAROSTENT® FAST™ Biliary (NNN) HANAROSTENT® Esophageal TTS (NCN) HANAROSTENT® Esophageal TTS (CCC) HANAROSTENT LowAx Duodenum/Pylorus (NNN) HANAROSTENT LowAx Colon/Rectum (NNN) HANAROSTENT® Trachea/Bronchium (CCC) HANAROSTENT® Esophagus Asymmetric (CCC) HANAROSTENT® Benefit™ Biliary (NNN) HANAROSTENT® Biliary (NNN)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility