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Medical DevicesKOSDAQ 042520156 approvals

HANS BIOMED CORPORATION

Official website

KOSDAQ-listed medical device company producing human tissue implants Bella Cell HD and SureFuse.

As of 2026-10-10, HANS BIOMED CORPORATION has 150 Korean MFDS device approvals, 6 US FDA clearances/approvals, 2 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

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Market cap

Business overview

Source: DART corporate disclosure

Founded in 1999 and listed on KOSDAQ in 2009, Hans Biomed is a human tissue implant and medical device company. It produces skin and bone tissue implants Bella Cell HD and SureFuse, and medical devices including Mint and hair transplant devices, alongside silicone materials and affiliate cosmeceutical products. Tissue implant products account for about 61% of revenue and medical devices about 32%, with headquarters in Songpa-gu, Seoul, R&D and production facilities in Daejeon, and overseas subsidiaries in the US, Thailand, and the UK.

Products & technology

  • Bella Cell HDskin tissue implant
  • SureFusebone tissue implant
  • Mintmedical device
  • hair transplant devicehair transplantation medical device

Regulatory approvals

data.go.kr · openFDA

150 Korean MFDS device approvals · 1999–2026 / 6 US FDA 510(k) · 2016–2026

  • FDAMINT MONO Sutures2026-09-18
    510(k) · TraditionalGeneral, Plastic SurgeryK254238
  • MFDSImplantation assistant, inserter2026-08-11
    Product approval · Class 1제신 26-993 호
  • MFDSBarrier, intra oral, resorbable2026-01-29
    Product approval · Class 4제허 26-90 호
  • MFDSImplantation assistant, inserter2025-10-28
    Product approval · Class 1제신 25-1426 호
  • MFDSBone graft material, human source2025-09-09
    Product approval · Class 4제허 25-619 호
  • MFDSPolydioxanone suture2025-07-16
    Product approval · Class 4제허 25-474 호
  • MFDSPolydioxanone suture2025-06-26
    Product approval · Class 4제허 25-419 호
  • MFDSDressing, fluid-impermeable film2025-04-28
    Product approval · Class 2제인 25-4357 호
  • MFDSimplant, endosseous, fixtureRevoked2025-03-10
    Product approval · Class 3제허 25-143 호
  • MFDSIrrigation syringeRevoked2025-02-12
    Product approval · Class 1제신 25-145 호
  • MFDSThread for facial tissue fixation, absorbable or non-absorbable2024-11-12
    Product approval · Class 4제허 24-784 호
  • MFDSBone graft, human sourceRevoked2024-08-14
    Product approval · Class 4제허 24-554 호
Show 68 more
  • MFDSBone graft, human sourceRevoked2024-08-14
    Product approval · Class 4제허 24-553 호
  • MFDSNeedle, aspiration/injection, reusable2024-05-24
    Product approval · Class 1제신 24-646 호
  • MFDSBone graft, human sourceRevoked2024-03-20
    Product approval · Class 4제허 24-202 호
  • MFDSBone graft, human sourceRevoked2024-03-20
    Product approval · Class 4제허 24-201 호
  • MFDSDressing, fluid-impermeable film2024-02-14
    Product approval · Class 2제인 24-162 호
  • MFDSPolydioxanone suture2023-08-07
    Product approval · Class 4제허 23-824 호
  • MFDSHemostat, internal, absorbable2023-06-29
    Product approval · Class 4제허 23-731 호
  • MFDSPolyglycolic acid suture2023-05-31
    Product approval · Class 4제허 23-629 호
  • MFDSSuture, polyglecaprone2023-05-31
    Product approval · Class 4제허 23-622 호
  • MFDSDressing, topical hemostasis, externalRevoked2023-03-29
    Product approval · Class 2제인 23-4593 호
  • FDAMINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 10142023-03-07
    510(k) · TraditionalGeneral, Plastic SurgeryK220549
  • MFDSNeedle, suture, general-purpose2023-02-13
    Product approval · Class 1제신 23-175 호
  • MFDSPolydioxanone suture2022-10-28
    Product approval · Class 4제허 22-726 호
  • MFDSThread for facial tissue fixation, absorbable or non-absorbable2022-01-24
    Product approval · Class 4제허 22-50 호
  • MFDSThread for facial tissue fixation, absorbable or non-absorbable2022-01-24
    Product approval · Class 4제허 22-49 호
  • MFDSThread for facial tissue fixation, absorbable or non-absorbable2022-01-06
    Product approval · Class 4제허 22-8 호
  • MFDSBreast prosthesis, internal, gel-filledRevoked2021-09-24
    Product approval · Class 4제허 21-787 호
  • MFDSNeedle, suture, general-purpose2021-08-04
    Product approval · Class 1제신 21-1063 호
  • MFDSSurgical suture, non-absorbable, with/without needle2021-06-10
    Product approval · Class 3제허 21-467 호
  • MFDSImplantation assistant, inserter2021-05-14
    Product approval · Class 1제신 21-678 호
  • MFDSTissue supplement, collagen2021-01-26
    Product approval · Class 4제허 21-63 호
  • MFDSTissue supplement, collagen2021-01-25
    Product approval · Class 4제허 21-60 호
  • MFDSBone graft, human sourceRevoked2020-11-03
    Product approval · Class 4제허 20-928 호
  • MFDSSizer, breast prosthesis2020-10-15
    Product approval · Class 2제인 20-4931 호
  • FDAMINT Product Family2020-09-09
    510(k) · TraditionalGeneral, Plastic SurgeryK192423
  • MFDSTissue reconstructive material, synthetic, silicone, block2020-08-21
    Product approval · Class 3제허 20-688 호
  • MFDSPolydioxanone suture2019-11-19
    Product approval · Class 4제허 19-739 호
  • MFDSSizer, breast prosthesis2019-11-13
    Product approval · Class 2제인 19-4933 호
  • MFDSDressing, fluid-impermeable film2019-11-08
    Product approval · Class 2제인 19-4916 호
  • MFDSPolyglycolic acid sutureRevoked2019-07-17
    Product approval · Class 4제허 19-465 호
  • MFDSSuture, polyglecaproneRevoked2019-07-17
    Product approval · Class 4제허 19-463 호
  • MFDSHair implant system2019-06-13
    Product approval · Class 2제인 19-4473 호
  • MFDSSubsidiary: 한스케어 주식회사Nasal splint, external2018-12-31
    Product approval · Class 1제신 18-1740 호
  • MFDSNeedle, suture, general-purposeRevoked2018-08-01
    Product approval · Class 1제신 18-978 호
  • MFDSTissue reconstructive material, synthetic, silicone, block2018-04-17
    Product approval · Class 3제허 18-261 호
  • MFDSGraft/prosthesis, biomaterial2018-04-11
    Product approval · Class 4제허 18-245 호
  • MFDSTissue supplement, collagen2018-03-22
    Product approval · Class 4제허 18-191 호
  • MFDSTissue reconstructive material, synthetic, silicone, block2018-02-26
    Product approval · Class 3제허 18-123 호
  • FDASurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty2018-02-22
    510(k) · TraditionalOrthopedicK171568
  • MFDSBreast prosthesis, internal, gel-filled2017-11-21
    Product approval · Class 4제허 17-887 호
  • MFDSGraft/prosthesis, biomaterial2017-09-13
    Product approval · Class 4제허 17-698 호
  • MFDSBone graft, human source2017-08-31
    Product approval · Class 4제허 17-663 호
  • MFDSTissue reconstructive material, synthetic, silicone, block2017-04-27
    Product approval · Class 3제허 17-292 호
  • MFDSBone graft, human source2017-02-16
    Product approval · Class 4제허 17-120 호
  • MFDSThread for facial tissue fixation, absorbable or non-absorbable2016-11-15
    Product approval · Class 4제허 16-847 호
  • MFDSHemostat, internal, absorbableRevoked2016-11-02
    Product approval · Class 4제허 16-796 호
  • MFDSDressing, fluid-impermeable film2016-09-02
    Product approval · Class 2제인 16-4723 호
  • MFDSThread for facial tissue fixation, absorbable or non-absorbable2016-06-20
    Product approval · Class 4제허 16-436 호
  • MFDSTrocar2016-04-28
    Product approval · Class 1제신 16-519 호
  • MFDSNeedle, suture, general-purpose2016-04-27
    Product approval · Class 1제신 16-517 호
  • FDAMaxiGen2016-04-21
    510(k) · TraditionalOrthopedicK152077
  • MFDSBreast prosthesis, internal, gel-filled2016-04-21
    Product approval · Class 4제허 16-308 호
  • MFDSBone graft, human source2016-04-18
    Product approval · Class 4제허 16-303 호
  • FDABellaFuse2016-03-11
    510(k) · TraditionalOrthopedicK151271
  • MFDSTissue supplement, collagen2016-02-05
    Product approval · Class 4제허 16-99 호
  • MFDSGraft/prosthesis, biomaterial2015-12-03
    Product approval · Class 4제허 15-1640 호
  • MFDSBreast prosthesis, internal, gel-filled2015-11-27
    Product approval · Class 4제허 15-1620 호
  • MFDSBone graft, human sourceRevoked2015-11-25
    Product approval · Class 4제허 15-1617 호
  • MFDSSizer, breast prosthesis2015-08-31
    Product approval · Class 2제인 15-4085 호
  • MFDSSuture, absorbableRevoked2015-06-08
    Product approval · Class 4제허 15-895 호
  • MFDSBone graft material, human source2015-04-24
    Product approval · Class 4제허 15-634 호
  • MFDSDressing, fluid-impermeable film2015-03-11
    Product approval · Class 2제인 15-350 호
  • MFDSGraft, bone, syntheticRevoked2014-07-27
    Product approval · Class 4제허 14-1390 호
  • MFDSGraft, bone, syntheticRevoked2014-07-27
    Product approval · Class 4제허 14-1391 호
  • MFDSThread for facial tissue fixation, absorbable or non-absorbable2014-06-25
    Product approval · Class 4제허 14-1219 호
  • MFDSDressing, fluid-impermeable filmRevoked2014-06-17
    Product approval · Class 2제인 14-1180 호
  • MFDSGraft, bone, syntheticRevoked2014-05-22
    Product approval · Class 4제허 14-1062 호
  • MFDSThread for facial tissue fixation, absorbable or non-absorbable2014-05-22
    Product approval · Class 4제허 14-1065 호

Showing the 80 most recent of 156 records.

R&D and key agreements

Source: DART corporate disclosure

조직공학 및 신의료기술 R&D · 혈관지혈장치 등 · 연구개발 진행중 · R&D in tissue engineering and new medical technologies including vascular hemostatic devices at company and affiliate research centers

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 94 more patents

AI reads

MAA server logs · IP-verified
113
Times AI engines pulled HANS BIOMED CORPORATION's records

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

6
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Last 7 days
92
live 3
Last 30 days
113
live 5
All time
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  • OpenAIOAI-SearchBot93
  • GoogleGoogleOther8
  • PerplexityPerplexityBot4
  • AnthropicClaudeBot2
  • MicrosoftBingbot1

Measured since Aug 27, 2026 · 5 AI engines · last read Oct 9, 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.

DongBang Medical Co., Ltd.9 shared

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

METABIOMED.CO.,LTD9 shared

KOSDAQ-listed medical device company manufacturing synthetic bioresorbable suture yarn and dental root canal filling materials.

CELLUMED CO., LTD.8 shared

KOSDAQ-listed holding company making medical devices and biologics including bone graft rhBMP2 and knee implant TKR.

Samyang Biopharm Corporation7 shared

Founded and KOSPI-listed in 2025, Samyang Biopharm develops medical devices, pharmaceuticals, and new drug candidates.

OSTEONIC Co., Ltd.7 shared

Established in 2012 and listed on KOSDAQ in 2018, Osteonic manufactures implants for the CMF, Trauma, Sports Medicine, and Spine categories.

Hanmi Science Co.,Ltd6 shared

KOSPI-listed operating holding company of the Hanmi Pharm group, also running healthcare and pharmaceutical wholesale businesses.

CG MedTech Co.,Ltd.6 shared

Founded in 1997 and KOSDAQ-listed in 2015, CG MedTech makes orthopedic medical devices and also operates an electric energy business.

Alpha AI Co.,Ltd.6 shared

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

L&C BIO Co., Ltd5 shared

L&C BIO manufactures human tissue grafts across 11 tissue types, including the acellular dermal matrix MegaDerm, plus tissue-based medical devices.

SHINHUNG CO.,LTD5 shared

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

JETEMA Co.,Ltd.5 shared

Founded 2009, listed on KOSDAQ in 2019, JETEMA develops hyaluronic acid fillers, botulinum toxin biopharmaceuticals, and lifting threads.

PharmaResearch Co., Ltd.5 shared

KOSDAQ-listed medical device company producing PDRN pharmaceuticals, HA fillers, and Rejuran-branded cosmetics.

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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