Medical DevicesKONEX 40242064 approvals

CALTH. Inc

Official website

Holds manufacturing approvals for 42 point-of-care diagnostic reagents and devices in the IVD market.

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Business overview

Source: DART corporate disclosure

Founded in 2018 and listed on KONEX in 2021, Calth is a medical device company specializing in in vitro diagnostics (IVD). It holds manufacturing approvals for 42 point-of-care diagnostic reagents and devices, including three for high-risk infectious viral diseases, and produces and sells them. It is developing a saliva diagnostic system based on ion concentration polarization (ICP) and Nano-trap pretreatment technology, rapid diagnostic reagents for anti-HIV and anti-HCV, a point-of-care molecular diagnostic reagent (LAMP PCR), and a deep-learning-based analysis platform, while also researching a diagnostic method for acute ischemic stroke using exosomal miRNA markers in blood.

Products & technology

Point-of-care diagnostic reagents and devices (42 items)Point-of-care diagnostics including 3 items for high-risk infectious viral diseases
Saliva diagnostic system (anti-HIV, anti-HCV)Rapid saliva-based diagnosis using ICP and Nano-trap pretreatment technology
LAMP PCRPoint-of-care molecular diagnostic reagent

Regulatory approvals

data.go.kr

64 Korean MFDS device approvals · 2014–2026

MFDSIVD reagents for Infectious disease marker(Detection of low infectivity pathogen), immunological method2026-08-19
Product approval · Class 2체외 제인 26-4761 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological method2025-07-29
Product approval · Class 3체외 제허 25-524 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological method2025-07-29
Product approval · Class 3체외 제허 25-523 호
MFDSIVD strip for endocrine self test2025-03-12
Product approval · Class 2체외 제인 25-4191 호
MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2024-12-18
Product approval · Class 4체외 제허 24-882 호
MFDSConcentration/extraction devices2024-11-26
Product approval · Class 1체외 제신 24-1471 호
MFDSImmunoabsorbance analyzer2024-11-06
Product approval · Class 1체외 제신 24-1360 호
MFDSIVD strip for endocrine self test2024-08-30
Product approval · Class 2체외 제인 24-816 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological method2024-06-18
Product approval · Class 3체외 제허 24-405 호
MFDSIVD strip for endocrine self test2024-04-24
Product approval · Class 2체외 제인 24-428 호
MFDSIVD reagent for infectious disease, immunological method2024-04-23
Product approval · Class 3체외 제허 24-280 호
MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2023-10-11
Product approval · Class 4체외 제허 23-968 호

Show 52 more

MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological method2023-07-25
Product approval · Class 3체외 제허 23-797 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2023-06-20
Product approval · Class 3체외 제허 23-684 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological method2023-06-07
Product approval · Class 3체외 제허 23-642 호
MFDSIVD reagents for extracting nucleic acids2022-10-07
Product approval · Class 1체외 제신 22-1388 호
MFDSExtractor, nucleic acid2022-10-06
Product approval · Class 1체외 제신 22-1378 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological method2022-09-14
Product approval · Class 3체외 제허 22-612 호
MFDSCapillary blood collection tube2022-06-29
Product approval · Class 1수신 22-1105 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological method2022-01-13
Product approval · Class 3체외 제허 22-19 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2021-12-07
Product approval · Class 3체외 제허 21-985 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological method2021-09-16
Product approval · Class 3체외 제허 21-774 호
MFDSCapillary blood collection tube2021-07-23
Product approval · Class 1수신 21-1393 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological method2021-06-02
Product approval · Class 3체외 제허 21-442 호
MFDSImmunoabsorbance analyzer2021-03-30
Product approval · Class 1체외 제신 21-420 호
MFDSTool for specimensRevoked2020-12-30
Product approval · Class 1수신 20-2900 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological method2020-10-12
Product approval · Class 3체외 제허 20-875 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2020-09-23
Product approval · Class 3체외 제허 20-836 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological method2020-08-26
Product approval · Class 3체외 제허 20-727 호
MFDSCapillary blood collection tube2020-08-20
Product approval · Class 1수신 20-1958 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological method2020-05-21
Product approval · Class 3체외 제허 20-380 호
MFDSSpectrophotometer for clinical useRevoked2019-11-01
Product approval · Class 1체외 제신 19-1421 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological method2018-04-25
Product approval · Class 3체외 제허 18-305 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological method2015-04-15
Product approval · Class 3체외 제허 15-559 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological method2015-04-08
Product approval · Class 3체외 제허 15-497 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2015-04-08
Product approval · Class 3체외 제허 15-498 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological method2015-02-24
Product approval · Class 3체외 제허 15-236 호
MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2014-12-08
Product approval · Class 4체외 제허 14-2905 호
MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2014-12-08
Product approval · Class 4체외 제허 14-2906 호
MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological methodRevoked2014-12-08
Product approval · Class 4체외 제허 14-2907 호
MFDSIVD reagents for cardiac markerRevoked2014-12-08
Product approval · Class 3체외 제허 14-2908 호
MFDSIVD reagents for tumor markerRevoked2014-12-08
Product approval · Class 3체외 제허 14-2909 호
MFDSIVD reagents for tumor markerRevoked2014-12-08
Product approval · Class 3체외 제허 14-2910 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2014-12-08
Product approval · Class 3체외 제허 14-2911 호
MFDSIVD reagents for serotyping or patient monitoring of HIV, HBV, HCV, HTLV, immunological method2014-12-08
Product approval · Class 3체외 제허 14-2912 호
MFDSIVD reagents for serotyping or patient monitoring of HIV, HBV, HCV, HTLV, immunological methodRevoked2014-12-08
Product approval · Class 3체외 제허 14-2913 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological method2014-12-08
Product approval · Class 3체외 제허 14-2914 호
MFDSIVD reagents for diagnostic blood coagulation testRevoked2014-12-04
Product approval · Class 3체외 제허 14-2806 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2014-12-04
Product approval · Class 3체외 제허 14-2807 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2014-12-03
Product approval · Class 3체외 제허 14-2775 호
MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2014-12-03
Product approval · Class 3체외 제허 14-2776 호
MFDSIVD reagents for tumor markerRevoked2014-12-03
Product approval · Class 3체외 제허 14-2777 호
MFDSIVD reagents for tumor markerRevoked2014-12-03
Product approval · Class 3체외 제허 14-2778 호
MFDSIVD reagents for cardiac markerRevoked2014-12-03
Product approval · Class 3체외 제허 14-2779 호
MFDSIVD reagents for cardiac markerRevoked2014-12-03
Product approval · Class 3체외 제허 14-2780 호
MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2014-12-03
Product approval · Class 4체외 제허 14-2781 호
MFDSIVD reagents for fecal occult blood testRevoked2014-11-21
Product approval · Class 2체외 제인 14-2377 호
MFDSIVD reagents for Infectious disease marker(Detection of low infectivity pathogen), immunological method2014-11-21
Product approval · Class 2체외 제인 14-2378 호
MFDSIVD reagents for fecal occult blood test2014-11-21
Product approval · Class 2체외 제인 14-2379 호
MFDSIVD strip for endocrine self test2014-11-21
Product approval · Class 2체외 제인 14-2380 호
MFDSIVD strip for endocrine self test2014-11-21
Product approval · Class 2체외 제인 14-2381 호
MFDSIVD Reagents for thyroid function hormone testsRevoked2014-11-21
Product approval · Class 2체외 제인 14-2382 호
MFDSIVD strip for endocrine self test2014-11-21
Product approval · Class 2체외 제인 14-2383 호
MFDSIVD strip for endocrine self test2014-11-21
Product approval · Class 2체외 제인 14-2384 호

R&D and key agreements

Source: DART corporate disclosure

딥러닝 기반 분석플랫폼 · 개발 중 · Developing a deep-learning-based platform for diagnostic data analysis

액체생검 기반 뇌졸중 진단법 · 급성 허혈성뇌졸중 · 마커 개발 및 데이터베이스 구축 중 · Developing exosomal miRNA marker-based diagnosis and treatment monitoring for acute ischemic stroke

Not yet compiled: business overview. Send us materials and we will add them

Companies approved for the same productsMedical Devices

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

Boditech Med Inc.17 shared

KOSDAQ-listed point-of-care immunodiagnostics company supplying diagnostic cartridges and the ichroma/AFIAS instrument series.

SD BIOSENSOR INC.17 shared

KOSPI-listed in-vitro diagnostics company known for the STANDARD Q antigen/antibody test kits.

OSANG HEALTHCARE CO.,LTD.16 shared

Founded 1996, listed on KOSDAQ in 2024, OSANG HEALTHCARE develops and sells biochemistry, immunodiagnostic, and molecular IVD products.

GC Medical Science Corporation16 shared

GC Medical Science Corporation, KOSDAQ-listed since 2014, operates diagnostic reagent, blood glucose, and hemodialysis solution businesses.

HUMASIS CO., LTD.14 shared

KOSDAQ-listed IVD company producing COVID-19 and HIV point-of-care diagnostic reagents alongside rubber products and entertainment businesses.

NanoenTek,Inc.12 shared

Founded in 1987 and listed on KOSDAQ in 2000, NanoenTek develops Lab-On-a-Chip in-vitro diagnostic devices and life science instruments.

Precision Biosensor Inc.12 shared

KOSDAQ-listed IVD company producing time-resolved fluorescence immunodiagnostic products under the Exdia TRF brand.

Sugentech, Inc.12 shared

Founded in 2011 and KOSDAQ-listed in 2019, Sugentech develops multiplex immunoblot, point-of-care, and digital healthcare diagnostics.

PCL. Inc10 shared

KOSDAQ-listed IVD company using SG Cap™ multiplex diagnostic technology for infectious disease, cancer, and companion animal testing.

RollingStone Co., Ltd.7 shared

KOSDAQ-listed in-vitro diagnostics company developing the LabChip-based VERI-Q molecular diagnostic device series.

Micro Digital Co., Ltd.7 shared

KOSDAQ-listed bioprocess and biomedical company supplying the CELBIC single-use cell culture system and the DxBIC automated analysis system.

Median Diagnostics Inc.5 shared

Founded in 1999 and listed on KONEX in 2017, Median Diagnostics develops and manufactures immunoassay, molecular, and point-of-care in vitro diagnostic kits for animal diseases.

Sources and updates

Company basics: Korea Exchange · DART
Business content: Compiled from disclosure filings
AI visibility: Measured 2026-08-13

This page is compiled from public sources without the company's involvement. If anything is inaccurate or incomplete, please let us know. Materials provided by the company are labelled as such.

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