Company

    HISTORY

    HISTORY

    2011 ~ Present

    2023
    06

    Established Sejong Campus PIUM

    05

    Sugentech C.I Renewal

    03

    Approved by FDA Class 1 - SUREARLY™ SMART

    Listed in CE-IVDR(EU) S-Blot 2

    02

    Obtained domestic manufacturing approval - SGTi-flexM COVID-19 & Flu A/B Ag DUO

    2022
    12

    Obtained domestic manufacturing approval - SGTi-flex COVID-19 & Flu A/B Ag Combo

    Export USD 50 Million Tower Award

    11

    Launching digital healthcare platform, SUREARLY™ SMART

    08

    Obtained MDSAP certification

    03

    Type 1 diabetes diagnostic kit is approved manufacturing certification by Korea MFDS

    SGTi-flex COVID-19 Ag(Self test) is approved by ANVISA(Brazil)

    02

    Contract for supply of SGTi-COVID-19 Ag self-kit with Public Procurement Service

    01

    SGTi-flex COVID-19 Ag is approved by Health Canada

    SGTi-flex COVID-19 Ag(Self test) is approved by UAE, Kazakhstan and Switzerland OTC

    2021
    10

    Autoimmune disease diagnostic kit is approved manufacturing certification by Korea MFDS

    08

    SGT SARS-CoV-2 In Vitro Neutralizing Antibody Test (IVnAT) is approved by Malaysia

    07

    SGTi-flex COVID-19 Ag(Self test) is approved by UK

    06

    SGTi-flex COVID-19 Ag(Self test) is approved by Vietnam

    05

    SGTi-flex COVID-19 Ag(Self test) is approved by Greece

    INCLIX™ D-Dimer is approved by Korea MFDS

    SGTi-flex COVID-19 IgM/IgG(Self test) is approved by CE CoC

    04

    SGTi-flex COVID-19 Ag(Self test) is approved by BfArM(Germany)

    Surearly™ Smart Ovulation test is approved manufacturing certification by Korea MFDS

    SGT SARS-CoV-2 In Vitro Neutralizing Antibody Test (IVnAT) is approved by Korea MFDS

    Headquarters relocated: 2nd floor, Research Building 1, 70, Yuseong-daero 1689beon-gil, Yuseong-gu, Daejeon

    03

    S-Blot(Immunoblot automation system for Allergy test) is listed in CE-IVD DoC

    02

    SGTi-flex COVID-19 Ag is approved by Philippine

    SGTi-flex COVID-19 IgG is approved by Russia

    01

    Surearly™ Smart Pregnancy test is approved manufacturing certification by Korea MFDS

    SGT SARS-CoV-2 In Vitro Neutralizing Antibody Test (IVnAT) is listed in CE-IVD DoC

    SGTi-flex COVID-19 & Flu A/B Ag DUO is listed in CE-IVD DoC

    2020
    12

    SGTi-flex COVID-19 IgM/IgG, IgG is approved manufacturing certification by Korea MFDS

    11

    SGTi-flex COVID-19 Ag is approved by ANVISA(Brazil)

    10

    SGTi-flex COVID-19 Ag is approved by Singapore

    SGTi-flex COVID-19 & Flu A/B Ag Duo is approved by Korea MFDS

    SGT Anti-SARS-COV-2 Total Ab ELISA is listed in CE-IVD

    SGTi-flex COVID-19 Ag is approved by Peru

    SGTi-Allergy Screen(Inhalant, Food, Combined) is listed in CE-IVD

    SGTi-flex COVID-19 Ag is approved by Bolivia

    SGTi-flex COVID-19 Ag is listed in CE-IVD

    09

    SGTi-flex COVID-19 IgG is approved by FDA EUA

    08

    SGTi-flex COVID-19 IgM/IgG is approved by ANVISA(Brazil)

    SGTi-flex COVID-19 IgM/IgG is approved by Chile

    07

    SGTi-flex COVID-19 IgM/IgG is approved by Peru

    06

    SGTi-Allergy Screen(Inhalant, Food, Combined) is approved manufacturing certification by Korea MFDS

    2019 ~ 2015

    2019
    05

    Sugentech Co., Ltd. listed on KOSDAQ

    2018
    12

    Received the "Minister of Trade, Industry and Energy Award" at the Korea Technology Awards

    07

    Designated as "Export Promising Small and Medium Business" by the Ministry of SMEs and Startups

    06

    Designated as the lead company of the "National Dementia Overcoming Technology Development Project" by the Minister of Health and Welfare

    05

    Designated as the lead company for the "Bio industry core technology development project" by the MTI(Ministry of Trade and Industry)

    01

    Designated as a high-tech company by the Ministry of Science and ICT

    2017
    11

    Awarded the Chairman's Commendation Award of the National Assembly Health and Welfare Committee

    Medical device GMP certified (Osong Plant)

    10

    Designated as "K-Brain Power" by the MTI(Ministry of Trade and Industry)

    08

    NGSP certified

    06

    M&A the K-MAC Bio center

    01

    Received the grand prize of the 2017 Korea First Brand Award

    2016
    11

    Sugentech Co., Ltd. listed on KONEX

    10

    INCLIX™ Professional POCT system is listed in CE

    07

    Designated as the lead company for the "Investor-linked technology development project" by the MTI(Ministry of Trade and Industry)

    Designated as the lead company for the "Technology commercialization help platform commercialization development project" by the MTI(Ministry of Trade and Industry)

    05

    Designated as a participating company for the "Infectious disease crisis response technology development project" by the Minister of Health and Welfare

    04

    Surearly™ Digital Pregnancy test RFU and Pregnancy test strip is FDA Registered

    Designated as the participating company of the "Bio/medical technology development project" by the Ministry of Science and ICT

    03

    Signed ODM contract with Dong-A Pharmaceutical Co., Ltd for Early Sign Pregnancy test

    2015
    12

    Ampli & Array technology obtains New Excellent Technology(NET) certification by Korea Health Industry Promotion Agency

    11

    Signed a contract with Autotelic in the US for the development of anticancer drug Paclitaxel TDM

    10

    Awarded the Minister of Science and Technology Information and Communication Award

    Surearly™ Digital Multi-use Pregnancy test and Surearly™ Early Sign Pregnancy test is listed in CE

    01

    Surearly™ Digital Ovulation, Pregnancy test and 2 other products is listed in CE

    2014 ~ 2011

    2014
    11

    Designated as the lead company of the "R&D special zone research institute enterprise promotion project" by the Ministry of Science and ICT

    10

    Received the Korea Biochip Society Technology Award

    Acquired GMP certification for medical devices (Daejeon Plant)

    05

    Surearly™ Digital Ovulation test is FDA Registered

    2013
    10

    ISO13485 certified (TÜV SÜD)

    Acquired a medical device manufacturing license in Korea

    08

    Designated as a participating company for the "Regional economic zone cooperation project" by the MTI(Ministry of Trade and Industry)

    06

    Designated as the lead company of the "Corporate Service R&D Project" by the Ministry of SMEs and Startups

    2012
    09

    Amli&Array technology wins Frost & Sullivan 2012 Asia Pacific Technology Innovation Award

    06

    Designated as the lead company of the "Research and Development Zone Research Center Enterprise Promotion Project" by the Ministry of Science and ICT

    05

    Designated as the lead company of the "Startup Growth Technology Development Project" by the Ministry of SMEs and Startups

    02

    Approved as a venture company

    2011
    12

    Registered as "R&D special zone No. 28 research company" by the Ministry of Science and ICT

    Establishment of corporation: Technology transfer of ‘Ubiquitous Biochip Reader’ from ETRI (Electronics and Telecommunications Research Institute)