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Company Introduction

회사소개 이미지

History.

Humasis continuously reaches out to the wider markets

2023
  • 04

    Acquired permission to produce COVID-19/Flu Ag Combo Test

  • 03

    Changed CEO (Cha Jeong-hak → Kim Sung-gon)

    Won a citation award as a trusted tax payer (National Tax Service)

2022
  • 12

    Acquired permission to produce COVID-19 Molecular Diagnostics Kit (COVID-19 RT-PCR Kit, for domestic use)

  • 11

    Acquired permission to export Humasis COVID-19 AgN Test

    Acquired permission to export Humasis hs-Malaria P.f/Pan Antigen Test

    Acquired KGMP certificate for Anyang Factory

  • 09

    Established US corporation

  • 08

    Launched HUBI DIA

  • 07

    Acquired certificate for Humasis COVID-19Ag Home Test Health Canada

  • 06

    Made strategic investment to CareforU

  • 05

    Started operation of molecular diagnostics kit production facilities

  • 03

    Acquired permission to produce COVID-19 Variant Virus Molecular Diagnostics Kit (COVID-19 Variant RT-qPCR Kit, for export)

  • 02

    Acquired permission to produce COVID-19 Molecular Diagnostics Kit (COVID-19 RT-qPCR Kit ,for export)

    Acquired KGMP certificate for Uiwang Factory

    Acquired CE certificate for COVID-19 Antigen Test Kit (COVID-19 Ag Home Test)

2021
  • 12

    Won 30 Million Dollar Export Tower Award in 2021 (Korea International Trade Association)

  • 11

    Established branch : A case on registration of Geumjeong-dong branch

  • 09

    Established branch : A case on registration of Uiwang Factory branch

  • 08

    Acquired permission on exporting COVID-19 RBD/IgG Antigen Test Kit

    Acquired official permission on COVID-19 Antigen Self-Test Kit (COVID-19 Ag Test)

  • 06

    Acquired COVID-19 Antigen Test Kit (COVID-19 Ag Test) for Vietnam

  • 05

    Acquired COVID-19 Antigen Test Kit (COVID-19 Ab Test) for South Korea

  • 04

    Acquired conditional permission on COVID-19 Antigen Self-Test Kit (COVID-19 Ag Test)

    Acquired emergency use authorization on COVID-19 Antigen Test Kit (COVID-19 Ag Test) by US FDA

    Acquired KGMP certificate for Gunpo Factory

    Established branch : 37, Gunpocheomdansaneop 2-ro, Gunpo-si, Gyeonggi-do (Bugok-dong, Humasis GMP Factory)

  • 03

    Acquired domestic permission on COVID-19 Antigen Test Kit (COVID-19 Ag Test)

2020
  • 09

    Acquired permission to produce COVID-19 and Flu Test Kit (COVID-19/Flu Ag Combo Test) medical device (for export)

    Acquired CE certificate for COVID-19 Antigen Test Kit (COVID-19 Ag Test)

    Acquired permission to produce COVID-19 Antigen Test Kit (COVID-19 Ag Test) medical device (for export)

  • 06

    Signed a contract for joint development of COVID-19 Antigen Test Kit : Humasis-Celltrion

  • 03

    Acquired permission to produce COVID-19 Antigen Test Kit (COVID-19 IgG/IgM Test) medical device (for export)

    Acquired CE certificate for COVID-19 Antigen Test Kit (COVID-19 IgG/IgM Test)

  • 02

    Established Vietnam Corporation (Humasis VINA Co. Ltd)

Infinite Challenges to Become A Stronger Bio Company

2019
  • 08

    Constructed company buildings in Gunpo Valley

    Acquired permission to produce Humasis G6PD, HUBI Free T3 medical device (for export)

  • 06

    Acquired patent : Kit for Simultaneous Diagnosing HIV-2, 2, and O Using Immunologic Measurement, and Simultaneous Diagnosis Method Using Same

  • 01

    Acquired permission to produce HUBI TESTO, HUBI-IL6 medical device

2018
  • 09

    Released High-Sensitivity HIV Antigen Test Kit

  • 05

    Released portable urine analysis equipment (U-AQ Handy)

2017
  • 11

    Acquired GMP certificate from Brazilian Health Regulatory Agency (ANVISA), Ministry of Health, Brazil

  • 10

    Listed on KOSDAQ

  • 09

    Applied merger registration (completed)

  • 05

    Made board resolutions on merger and signed a merger contract

    Designated as a small giant company by Ministry of Employment and Labor

2016
  • 09

    Acquired CE certificate for Pregnancy Test Kit, Self-testing(Annex3.6)

  • 03

    Registered Pregnancy Test Kit (Indonesia)

  • 01

    Signed UNICEF LTA with Denmark, UNICEF

    “After” Pregnancy Test Kit won a brand award from Korea Satisfaction Consumer Index

2015
  • 12

    Won 3 Million Dollar Export Tower Award in 2015 (Korea International Trade Association)

  • 11

    Registered Malaria Test Kit (Nigeria)

    Released Influenza Test Kit and Influenza/RSV Test Kit

  • 07

    Signed MOU with Korea University Medical Device Development Center on medical device clinical trials

  • 03

    Signed MOU with Korea University Guro Hospital on in vitro diagnostic reagent and clinical trials

  • 02

    Acquired ANVISA certificate for Pregnancy Test Kit (Brazil)

2014
  • 11

    Entered into circulation markets such as marts/convenience stores (pregnancy/ovulation diagnosis reagent)

  • 04

    Converted medical device law enforcement related products (82 items) medical device import business license (No. 3482)

2013
  • 11

    Selected as a creative company by IB

  • 05

    Won P500 Project (No.20130510043)

Start of Humasis History and Efforts for Growth

2012
  • 07

    Acquired CE certificate for urinalysis (urine chemistry analyzer and reagent)

  • 01

    U.S. patent registration (diagnostic device using similar structure protein ratio measurement)

2011
  • 05

    Selected as a leading company for P300 international organization procurement (KOTRA, Korea Import & Export Corporation)

  • 02

    Selected as New Exporters 300’ company (Korea International Trade Association)

2009
  • 12

    Registered medical device factory (Electrodiagnostic and therapy device manufacturing business)

  • 10

    Acquired medical device manufacturing license (kFDA)

2008
  • 12

    Changed CEO (Cha Jeong-hak)

  • 10

    Acquired European CE certificate (Humasis PSA Card)

  • 02

    US patent registration of abnormal pregnancy test kit (Inex screen) (Registration number: 7332350)

  • 01

    Acquired European CE certificate (Humasis CK-MB, Humasis Myoglobin)

2007
  • 06

    Certified as INNOBIZ (No. 7025-2254, Class A)

2006
  • 04

    Obtained ISO 13485:2003, Acquired CE mark

2005
  • 08

    SME technology innovation competition technology innovation award (acute myocardial infarction test kit)

2004
  • 10

    Confirmed as a venture company (No. 041622021-1-00745)

  • 04

    ISO Certification (9001:2000/KS A 9001:2001 DAS Certification)

2003
  • 04

    Received approval for establishment of Central R&D Center (issued approval/certificate)

  • 09

    Released Hepatitis Test Tit (HBs Ag strip, card)

    Released Hepatitis Test Tit (anti-HBs strip, card)

    Abnormal pregnancy test kit (Inexscreen) PCT application

2001
  • 04

    Commenced sales of Pregnancy Test Kit

2000
  • 06

    Established the company (10F, Goun Advanced Science and Technology Research Institute, Suwon University, San 2-2, Wau-ri, Bongdam-eup, Hwaseong-gun, Gyeonggi-do)