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hans biomed

  • CEO
  • 우리회사는
    • 국내 1호 조직은행 설립
    • 아시아 최초 FDA 등록
    • 세계일류상품 인증기업
    • 국내 최대 조직공학 연구소 보유
    • 업계최초 코스닥 상장
  • 성장연혁
  • Vision 2022
  • 사업영역
    • Allograft Tissue
    • Silicone Polymer
    • Medical Device
    • Bio Technology
  • 인증현황
  • 글로벌 네트워크
  • 찾아오시는길

HomeHans BiomedAbout our company

우리회사는 아시하 최소 FDA등록

Hans Biomed Corp. was registered with the US FDA (Food and Drug Administration)in 2002, the first to do so in Asia.

The FDA conducts regular site inspections through external inspection bodies (quality control, manufacture and production facilities and lines, safety inspection etc.). At the time, Hans Biomed Corp. was evaluated as ‘a human tissue transplant research production facility with the world’s best facilities’. Since then, in November 2012, we used Demineralized Bone Matrix (DBM) products to obtain FDA 510K approval by the US FDA.

FDA 510K approval is compulsory to export medical devices. Considering the fact that the US market accounts for 50% of the world’s market, it can be said that the Korean bone transplant product technology has been recognized by the world. Based on our excellent technical background, Hans Biomed Corp. is promoting its excellent products to the world, and growing as a global leader.

The first FDA registration/ 510K approval

Hans Biomed Corp. was registered  with the US FDA (Food and Drug Administration)in 2002, the first to do so in Asia.