BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    INTROMEDIC CO., LTD

    Reg #: 3007244127 · FEI: 3007244127 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    INTROMEDIC CO., LTD
    Registration Number
    3007244127
    FEI Number
    3007244127
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Suite 1105 1106 E&C Venture Dream Tower 6-Cha, Guro Dong, Guro Gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K143663

    Owner / Operator

    Firm Name
    IntroMedic Co., Ltd.
    Operator Number
    10027343
    Address
    Suite 1105 1106, E&C Dream Tower 6 Cha Guro Dong, Guro Gu
    City
    Seoul
    State
    KR-11
    Postal Code
    08375
    Country
    KR
    Correspondent
    GuYeon Jung

    US Agent

    Business Name
    IntroMedic America Inc.
    Contact Name
    Minsung Kim
    Address
    10671 Jefferson St Ne
    City
    Minneapolis
    State
    MN
    ZIP
    55434
    Country
    US
    Email
    [email protected]
    Phone
    929 2259154

    Products

    Device Name Product Code
    System, Imaging, Gastrointestinal, Wireless, Capsule NEZ

    Proprietary Names

    MiroCam Capsule Endoscope System MiroCam Capsule: MC1200-B Data Cable: MR1000-D MiroCam Receiver: MR1100 MiroView Software: MiroView U 3, MiroView RTV, MiroView RTV-i Data Belt: MR1000-D(S), MR1000-D(M), MR1000-D(L) MiroCam Capsule: MC2000-B MiroCam Receiver: MR2000 Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L) MiroCam Software: MiroView U 4 Data Cable / Data Belt: MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L) MiroCam Capsule: MC1600-B

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device