BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    MiroCam Capsule Endoscope System

    Reg #: 3013684328 · FEI: 3013684328 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    IntroMedic Co., Ltd.
    Registration Number
    3013684328
    FEI Number
    3013684328
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    F-RTEK 4F, 11-25, Simin-daero 327 beon-gil, Dongan-gu
    City
    Anyang-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K123428

    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
    Jinyoung Lee

    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 Data CableL MR1000-D Data Belt: MR1000-D(M), MR1000-D(L) MiroView Software: MiroView U, MiroView RTV, MiroView RTVi MiroCam Capsule: MC1000-B MiroCam Receiver: MR1100

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198