BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SUGENTECH, INC.

    Reg #: 3010879605 · FEI: 3010879605 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    SUGENTECH, INC.
    Registration Number
    3010879605
    FEI Number
    3010879605
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    721-26, Jeongjungyeonje-ro, Osong-eup, Heungdeok-gu
    City
    Cheongju-si Chungbuk
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K142754

    Owner / Operator

    Firm Name
    Sugentech, Inc.
    Operator Number
    10046776
    Address
    721-26, Jeongjungyeonje-ro, Osong-eup, Heungdeok-gu
    City
    Cheongju-si
    State
    Chungbuk
    Postal Code
    28161
    Country
    KR

    US Agent

    Business Name
    IRC USA
    Contact Name
    Charles Mack
    Address
    2950 E Lindrick Dr.
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

    Device Name Product Code
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Tube, Collection, Capillary Blood GIO
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Test, Follicle Stimulating Hormone (Fsh), Over The Counter NGA

    Proprietary Names

    Surearly Digital Ovulation Test Surearly Ovulation Test Strip Surearly SMART Ovulation Test Surearly SMART Surearly SMART Ovulation Test Starter Kit pettyPip Surearly Digital Pregnancy Test Surearly Pregnancy Test Strip Surearly SMART Menopause Test

    Establishment Types

    Manufacture Medical Device Foreign Private Label Distributor