BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    PREGABLE ovulation&pregnancy test kit (PREGABLE PREGNANCY TEST)

    Reg #: 3013735968 · FEI: 3013735968 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    SMILELAB CO., LTD.
    Registration Number
    3013735968
    FEI Number
    3013735968
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    RB-106, 33, Sagimakgol-ro 62beon-gil, Jungwon-gu,, Seongnam-si, Gyeonggi-do, Republic of Korea
    City
    Seongnam-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K150022

    Owner / Operator

    Firm Name
    Smilelab Co., Ltd.
    Operator Number
    10055410
    Address
    RB-106, 33, Sagimakgol-ro 62beon-gil, Jungwon-gu,
    City
    Seongnam-si
    State
    Gyeonggi
    Postal Code
    13211
    Country
    KR
    Correspondent
    YOUNGHUN SONG

    Products

    Device Name Product Code
    Visual, Pregnancy Hcg, Prescription Use JHI
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX

    Proprietary Names

    PREGABLE ovulation&pregnancy test kit (PREGABLE PREGNANCY TEST)

    Establishment Types

    Foreign Private Label Distributor Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device