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Medical DevicesKOSDAQ 067630Orphan Drug99 approvals6 trials

HLB Life Science CO.,LTD.

Official website

Founded in 1998 and listed on KOSDAQ in 2008, HLB Life Science operates four business divisions: medicare, bio-development, medical devices, and energy.

As of 2026-10-08, HLB Life Science CO.,LTD. has 95 Korean MFDS device approvals, 2 US FDA clearances/approvals, 4 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

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Market cap

Products & technology

  • In-vitro diagnostic device components and OEM/ODM finished-product manufacturingDevelopment of immunoassay rapid POCT diagnostic reagent components (Malaria, HIV, Covid-19, Influenza) and OEM/ODM manufacturing
  • Disposable syringes and medical devices (HLB Life Science Tinico)Manufacture, sale and distribution (including import) of disposable syringes and medical devices; shape-memory alloy manufacturing
  • Solar EPC and waste-incineration heat business (HLB Solution, HLB Energy)Solar power engineering, procurement and construction (EPC); waste-incineration heat business
  • Validation consultingValidation consulting (equipment, room, computer system, process, GMP) for medical device, pharmaceutical and food manufacturers

Regulatory approvals

data.go.kr · openFDA

2 Orphan Drug designations · 2022 / 95 Korean MFDS device approvals · 1999–2026 / 2 US FDA 510(k) · 2024–2026

  • Orphan리보세라닙2022-10-28
    Orphan Drug designation · in development20220175489
  • Orphan파이로티닙2022-02-11
    Orphan Drug designation · in development20220014535
  • MFDSInjector, medication/vaccine, syringe2026-08-06
    Product approval · Class 2수인 26-4542 호
  • MFDSInjector, medication/vaccine, syringe2026-08-05
    Product approval · Class 2수인 26-4537 호
  • FDASofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)2026-05-21
    510(k) · SpecialGeneral HospitalK253112
  • MFDSLancet, manually-operated, single-useRevoked2026-03-25
    Product approval · Class 2수인 26-4204 호
  • MFDSLancet, automatic, single-useRevoked2026-03-19
    Product approval · Class 2수인 26-4190 호
  • MFDSCapillary blood collection tube2026-03-13
    Product approval · Class 1수신 26-558 호
  • MFDSTissue supplement, collagen2026-02-02
    Product approval · Class 4제허 26-100 호
  • MFDSIrrigation syringe2026-01-26
    Product approval · Class 1수신 26-216 호
  • MFDSIrrigation syringe2026-01-26
    Product approval · Class 1수신 26-215 호
  • MFDSIrrigation syringe2026-01-26
    Product approval · Class 1수신 26-214 호
Show 68 more
  • MFDSSuction system, general-purpose, line-powered2025-12-17
    Product approval · Class 2제인 25-5170 호
  • MFDSCapillary blood collection tube2025-11-25
    Product approval · Class 1제신 25-1560 호
  • FDASofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)2024-12-23
    510(k) · SpecialGeneral HospitalK241856
  • MFDSNeedle holder for blood collection tube2024-07-09
    Product approval · Class 1수신 24-1275 호
  • MFDSCapillary blood collection tube2024-01-26
    Product approval · Class 1수신 24-138 호
  • MFDSTube, blood collecting, sealed, evacuated2024-01-11
    Product approval · Class 1수신 24-47 호
  • MFDSTube, blood collecting, sealed, evacuated2023-11-29
    Product approval · Class 1수신 23-2763 호
  • MFDSCapillary blood collection tube2023-08-23
    Product approval · Class 1제신 23-1268 호
  • MFDSCapillary blood collection tube2023-07-19
    Product approval · Class 1제신 23-1120 호
  • MFDSNeedle, aspiration/injection, single-use2023-07-11
    Product approval · Class 2제인 23-4892 호
  • MFDSGlove, patient examination2022-06-13
    Product approval · Class 1수신 22-1009 호
  • MFDSCapillary blood collection tube2021-11-19
    Product approval · Class 1제신 21-1540 호
  • MFDSCapillary blood collection tube2021-09-30
    Product approval · Class 1제신 21-1315 호
  • MFDSTool for specimensRevoked2021-03-05
    Product approval · Class 1제신 21-300 호
  • MFDSTool for specimensRevoked2021-01-18
    Product approval · Class 1제신 21-59 호
  • MFDSTool for specimensRevoked2021-01-18
    Product approval · Class 1제신 21-58 호
  • MFDSInjector, medication/vaccine, syringe2021-01-12
    Product approval · Class 2제인 21-4020 호
  • MFDSNeedle, aspiration/injection, single-use2021-01-12
    Product approval · Class 2제인 21-4019 호
  • MFDSLancet, automatic, single-useRevoked2020-09-28
    Product approval · Class 2수인 20-4655 호
  • MFDSLancet, manually-operated, single-useRevoked2020-09-28
    Product approval · Class 2수인 20-4654 호
  • MFDSTool for specimens2020-06-22
    Product approval · Class 1수신 20-1476 호
  • MFDSTool for specimens2020-06-08
    Product approval · Class 1수신 20-1362 호
  • MFDSCapillary blood collection tube2020-05-20
    Product approval · Class 1수신 20-1181 호
  • MFDSCapillary blood collection tube2020-05-15
    Product approval · Class 1제신 20-655 호
  • MFDSCapillary blood collection tube2020-04-01
    Product approval · Class 1제신 20-464 호
  • MFDSTool for specimens2020-03-26
    Product approval · Class 1수신 20-767 호
  • MFDSCapillary blood collection tube2020-03-23
    Product approval · Class 1제신 20-385 호
  • MFDSGlove, patient examination2020-03-16
    Product approval · Class 1수신 20-658 호
  • MFDSGlove, patient examination2019-09-30
    Product approval · Class 1수신 19-2478 호
  • MFDSCapillary blood collection tube2019-08-22
    Product approval · Class 1제신 19-1124 호
  • MFDSGlove, surgical2019-08-21
    Product approval · Class 2수인 19-4559 호
  • MFDSCapillary blood collection tube2019-08-21
    Product approval · Class 1수신 19-2093 호
  • MFDSTool for specimens2019-07-25
    Product approval · Class 1수신 19-1818 호
  • MFDSCapillary blood collection tube2019-07-02
    Product approval · Class 1수신 19-1587 호
  • MFDSCapillary blood collection tube2019-06-21
    Product approval · Class 1수신 19-1483 호
  • MFDSCapillary blood collection tube2019-04-16
    Product approval · Class 1수신 19-857 호
  • MFDSTool for specimens2019-04-02
    Product approval · Class 1수신 19-737 호
  • MFDSGlove, patient examination2018-11-09
    Product approval · Class 1수신 18-2458 호
  • MFDSGlove, patient examination2018-07-09
    Product approval · Class 1수신 18-1411 호
  • MFDSCapillary blood collection tube2018-04-26
    Product approval · Class 1수신 18-891 호
  • MFDSTool for specimens2017-12-18
    Product approval · Class 1수신 17-3575 호
  • MFDSCapillary blood collection tubeRevoked2017-09-15
    Product approval · Class 1수신 17-2800 호
  • MFDSCapillary blood collection tubeRevoked2017-08-23
    Product approval · Class 1제신 17-973 호
  • MFDSIntravascular administration setRevoked2017-04-13
    Product approval · Class 2수인 17-4212 호
  • MFDSCapillary blood collection tube2017-04-11
    Product approval · Class 1수신 17-1088 호
  • MFDSInjector, medication/vaccine, syringe2016-12-07
    Product approval · Class 2제인 16-4916 호
  • MFDSCapillary blood collection tube2016-10-18
    Product approval · Class 1수신 16-2653 호
  • MFDSNeedle, filter2016-10-14
    Product approval · Class 2제인 16-4795 호
  • MFDSNeedle, aspiration/injection, reusable2016-07-19
    Product approval · Class 1제신 16-878 호
  • MFDSTool for specimens2016-06-01
    Product approval · Class 1수신 16-1441 호
  • MFDSTool for specimensRevoked2016-02-22
    Product approval · Class 1수신 16-461 호
  • MFDSLancet, automatic, single-use2016-02-11
    Product approval · Class 2수인 16-4092 호
  • MFDSNeedle, aspiration/injection, single-use2015-10-29
    Product approval · Class 2제인 15-4229 호
  • MFDSInjector, medication/vaccine, syringe2015-04-30
    Product approval · Class 2제인 15-662 호
  • MFDSIrrigation unit, general purpose, manually-operated2015-03-17
    Product approval · Class 1대전 제신 15-29 호
  • MFDSCapillary blood collection tubeRevoked2014-10-08
    Product approval · Class 1경인 수신 14-473 호
  • MFDSCapillary blood collection tube2014-09-29
    Product approval · Class 1경인 수신 14-457 호
  • MFDSCapillary blood collection tubeRevoked2014-09-29
    Product approval · Class 1경인 수신 14-456 호
  • MFDSCapillary blood collection tube2014-09-29
    Product approval · Class 1경인 수신 14-455 호
  • MFDSCapillary blood collection tubeRevoked2014-09-29
    Product approval · Class 1경인 수신 14-454 호
  • MFDSCapillary blood collection tubeRevoked2014-09-29
    Product approval · Class 1경인 수신 14-453 호
  • MFDSCapillary blood collection tubeRevoked2014-09-29
    Product approval · Class 1경인 수신 14-451 호
  • MFDSCapillary blood collection tube2014-09-29
    Product approval · Class 1경인 수신 14-452 호
  • MFDSCapillary blood collection tubeRevoked2014-09-29
    Product approval · Class 1경인 수신 14-450 호
  • MFDSCapillary blood collection tubeRevoked2014-09-29
    Product approval · Class 1경인 수신 14-449 호
  • MFDSCapillary blood collection tube2014-09-01
    Product approval · Class 1경인 제신 14-509 호
  • MFDSIrrigation syringe2014-05-09
    Product approval · Class 1대전 제신 14-110 호
  • MFDSCapillary blood collection tube2014-04-02
    Product approval · Class 1경인 제신 14-269 호

Showing the 80 most recent of 99 records.

Clinical trials

data.go.kr

6 MFDS clinical trial authorisations · 2012–2023 (Phase 3 2 · Phase 1 2 · Phase 2 1 · Phase 1/2a 1)

  • Phase 3파이로티닙정2023-03-21

    13 trial sites

  • Phase 2주사용 캄렐리주맙(SHR-1210), 아파티닙(리보세라닙) 메실레이트2021-09-10

    14 trial sites

  • Phase 1SP-25772021-01-07
  • Phase 1YN968D12016-02-25

    1 trial site

  • Phase 3YN968D12015-08-20

    1 trial site

  • Phase 1/2aYN968D12012-02-14

    1 trial site

R&D and key agreements

Source: DART corporate disclosure

리보세라닙(Rivoceranib) · 항암(표적항암제) · Holds domestic exclusive license (HLB Life Science R&D)

파이로티닙(Pyrotinib) · 항암(표적항암제) · Holds domestic exclusive license (HLB Life Science R&D)

G2M Project · 항암(표적항암제) · Holds domestic exclusive license (HLB Life Science R&D)

바이오인공간·지혈제·인간 세포외기질 · Pipeline of subsidiary HLB Cell

Key disclosures

KRX KIND via OpenDART
Show 3 more events

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 19 more patents

AI reads

MAA server logs · IP-verified
60
Times AI engines pulled HLB Life Science CO.,LTD.'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.

2
Fetched fresh mid-answer

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.

58
Index crawls

Collected as raw material for future answers.

0
Direct AI-tool queries (MCP)

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

12
live 0
Last 7 days
49
live 2
Last 30 days
60
live 2
All time
  • OpenAIChatGPT-Userlive2
  • OpenAIOAI-SearchBot47
  • GoogleGoogleOther4
  • PerplexityPerplexityBot3
  • MicrosoftBingbot2
  • AnthropicClaudeBot2

Measured since Aug 27, 2026 · 5 AI engines · last read Oct 8, 2026

User-agent strings can be forged, so we do not count them at face value. We count only requests matched against vendor-published IP ranges, or confirmed by forward-verified reverse DNS. MCP queries are actual calls to this index's tool endpoint.

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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.

DongBang Medical Co., Ltd.13 shared

KOSDAQ-listed medical device maker producing disposable acupuncture needles, cupping cups, and hyaluronic acid dermal fillers.

SHINHUNG CO.,LTD6 shared

Founded in 1964 and KOSPI-listed in 1991, Shinhung manufactures and distributes dental equipment and materials.

SEWOONMEDICAL CO,. LTD.6 shared

Founded in 1982 and KOSDAQ-listed in 2008, Sewoon Medical manufactures medical aspirators and catheters/tubes.

SD BIOSENSOR INC.6 shared

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

SEJONG MEDICAL Co.Ltd.,5 shared

Founded in 2010 and KOSDAQ-listed in 2018, Sejong Medical manufactures laparoscopic surgical instruments.

OSANG HEALTHCARE CO.,LTD.5 shared

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

Boditech Med Inc.4 shared

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

Access Bio, Inc.4 shared

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

GC Medical Science Corporation4 shared

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

Precision Biosensor Inc.3 shared

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

Alpha AI Co.,Ltd.3 shared

Alpha AI, founded in 1995 and KOSDAQ-listed in 2000, manufactures biocompatible metal implants and surgical instruments.

CALTH. Inc3 shared

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

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

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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