BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    i-CHROMA iFOB Controls

    Reg #: 3009491259 · FEI: 3009491259 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BODITECH MED INC.
    Registration Number
    3009491259
    FEI Number
    3009491259
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    43, Geodudanji 1-gil, Dongnae-myeon
    City
    Chuncheon Gangwon
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K132167

    Owner / Operator

    Firm Name
    Boditech Med Inc.
    Operator Number
    10046783
    Address
    43, Geodudanji 1-gil, Dongnae-myeon
    City
    Chuncheon
    State
    Gangwon
    Postal Code
    24398
    Country
    KR
    Correspondent
    Young Min Kim

    US Agent

    Business Name
    Immunostics Inc.
    Contact Name
    Jung Hee Kim
    Address
    38 industrial way east, suite 1
    City
    Eatontown
    State
    NJ
    ZIP
    07724
    Country
    US
    Email
    [email protected]
    Phone
    732 9180770

    Products

    Device Name Product Code
    Automated Occult Blood Analyzer OOX
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    i-CHROMA iFOB Controls

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)