Humasis

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

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

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

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

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

Established US corporation

Launched HUBI DIA

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

Made strategic investment to CareforU

Started operation of molecular diagnostics kit production facilities

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

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)

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

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

Established branch : A case on registration of Uiwang Factory branch

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)

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

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

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)

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

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)

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

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)

Established Vietnam Corporation (Humasis VINA Co. Ltd)

Constructed company buildings in Gunpo Valley

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

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

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

Released High-Sensitivity HIV Antigen Test Kit

Released portable urine analysis equipment (U-AQ Handy)

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

Listed on KOSDAQ

Applied merger registration (completed)

Made board resolutions on merger and signed a merger contract

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

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

Registered Pregnancy Test Kit (Indonesia)

Signed UNICEF LTA with Denmark, UNICEF

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

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

Registered Malaria Test Kit (Nigeria)

Released Influenza Test Kit and Influenza/RSV Test Kit

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

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

Acquired ANVISA certificate for Pregnancy Test Kit (Brazil)

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

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

Selected as a creative company by IB

Won P500 Project (No.20130510043)

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

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

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

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

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

Acquired medical device manufacturing license (kFDA)

Changed CEO (Cha Jeong-hak)

Acquired European CE certificate (Humasis PSA Card)

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

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

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

Obtained ISO 13485:2003, Acquired CE mark

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

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

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

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

Released Hepatitis Test Tit (HBs Ag strip, card)

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

Abnormal pregnancy test kit (Inexscreen) PCT application

Commenced sales of Pregnancy Test Kit

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