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Medical DevicesKONEX 40242064 approvals

CALTH. Inc

Official website

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

As of 2026-10-08, CALTH. Inc has 64 Korean MFDS device approvals, 10 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

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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

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 10 more patents

AI reads

MAA server logs · IP-verified
115
Times AI engines pulled CALTH. Inc's records

Pulled records become part of each AI's index and keep feeding its answers. When an AI cites from that index, nothing reaches our server — so actual citations are uncounted here and exceed this number.

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Times an AI needed something not yet in its index and fetched this page fresh while answering. Citations served from the index leave no trace here.

115
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Direct AI-tool queries (MCP)

Queries from users who connected this index to their own AI.

13
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Last 7 days
93
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Last 30 days
115
live 0
All time
  • OpenAIOAI-SearchBot91
  • GoogleGoogleOther16
  • PerplexityPerplexityBot5
  • AnthropicClaudeBot2
  • MicrosoftBingbot1

Measured since Aug 27, 2026 · 5 AI engines · last read Oct 6, 2026

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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.18 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.

Access Bio, Inc.12 shared

Founded in 2002 and KOSDAQ-listed in 2013, Access Bio develops rapid diagnostic tests for malaria, COVID-19, and other infectious diseases.

PCL. Inc10 shared

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

DONG-A ST CO.,LTD9 shared

Dong-A ST, spun off from Dong-A Socio Holdings in 2013 and KOSPI-listed, makes prescription drugs like Growtropin, Stillen, and Bacchus.

HLB PANAGENE Co., LTD.8 shared

Founded in 1976 and KOSDAQ-listed in 2000, HLB PANAGENE develops PNA-based molecular diagnostic and diagnostic automation products.

Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

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