BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    GENBODY INC.

    Reg #: 3014660585 · FEI: 3014660585 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GENBODY INC.
    Registration Number
    3014660585
    FEI Number
    3014660585
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3-18, 3-12, Eopseong 2-gil, Cheonan-si
    City
    Cheonan Chungnam
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K251916

    Owner / Operator

    Firm Name
    GenBody Inc.
    Operator Number
    10067610
    Address
    3-18, Eopseong 2-gil, Cheonan-si
    City
    Cheonan-si
    State
    Chungnam
    Postal Code
    31077
    Country
    KR

    US Agent

    Business Name
    Kwell Laboratories Inc.
    Contact Name
    Paul Kwon
    Address
    3420 De Forest Cir
    City
    Jurupa Valley
    State
    CA
    ZIP
    91752
    Country
    US
    Email
    [email protected]
    Phone
    949 5610664

    Products

    Device Name Product Code
    Coronavirus Antigen Detection Test System. QKP
    Over-The-Counter Covid-19 Antigen Test QYT

    Proprietary Names

    Genbody COVID-19 Ag GenBody COVID-19 Ag Home Test

    Establishment Types

    Manufacture Medical Device