Updated 23 October 2026
Cardiovascular device distributors in South Korea: 36 licensed establishments
South Korea has 36 licensed establishments in the Index and no independent distributor yet.
The Bastion Hale Distributor Index lists 36 establishments in South Korea whose registry records include cardiovascular: 0 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 0 manufacturers' own import or sales entities, 0 regulatory representatives, and 36 manufacturers or exporters, out of 928 medical device establishments in South Korea overall. The records come from US FDA (openFDA), MHRA UK and Health Canada, last seen on 23 October 2026.
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Include manufacturers, their own sales entities and regulatory representatives (36)
Manufacturers, companies that are a manufacturer's own import or sales arm, and regulatory representatives (authorised representatives, sponsors or registration holders with no import or distribution role). They are registered here but are not independent distributors.
- 1Samsung Electronics Co., Ltd.Suwon-si Gyeonggi, GD0 lines17 registrationssize 49.9
- 2GE ULTRASOUND KOREA, LTD.Seongnam-Si Gyeonggi, GD0 lines16 registrationssize 49.7
- 3TAEWOONG MEDICAL CO., LTDGimpo-Si Gyeonggi, Gyeonggi-Do0 lines15 registrationssize 52.9
- 4ALPINION MEDICAL SYSTEMS Co., Ltd.Gangseo-gu Seoul0 lines14 registrationssize 49.1
- 5INBODY CO., LTD.Cheonan-si Chungnam0 lines10 registrationssize 44.2
- 6DAESUNG MAREF CO., LTD.Gunpo-si Gyeonggi, Gyeonggi-do0 lines9 registrationssize 44.0
- 70 lines9 registrationssize 43.5
- 8BCM CO., LTD.Goyang-si Gyeonggi, Goyaing-si0 lines9 registrationssize 35.1
- 9MEDIANA CO., LTD.Wonju-Si, Gangwon-do, Gangwon-do0 lines8 registrationssize 43.5
- 10M.I. TECH CO., LTD.Pyeongtaek-Si, GD0 lines7 registrationssize 42.1
- 11THE STANDARD CO., LTD.Gunpo-si Gyeonggi, GD0 lines5 registrationssize 39.9
- 12SELVAS Healthcare, Inc.Yuseong-gu Daejeon0 lines3 registrationssize 32.4
- 13Siemens Healthineers Ltd.SEONGNAM-SI Gyeonggi0 lines2 registrationssize 38.0
- 14HUMANSCAN CO., LTD.Siheung-si Gyeonggi, GD0 lines2 registrationssize 35.9
- 15SEERS CO., LTD.Pyeongtaek Gyeonggi, GD0 lines2 registrationssize 31.0
- 160 lines2 registrationssize 24.0
- 17MEDICORE CO., LTD.Seongnam-si Gyeonggi0 lines2 registrationssize 23.0
- 18GENOSS Co., Ltd.Suwon-si Gyeonggi, Gyeonggi-do0 lines1 registrationsize 33.6
- 19HI MEDICAL CO., LTD.SEOUL0 lines1 registrationsize 32.3
- 20BIO PROTECH, INC.Wonju-si Gangwon0 lines1 registrationsize 32.2
Cardiovascular covers stents, catheters, pacemakers, heart valves, ECG and vascular access. Most products are implantable or high risk, which concentrates the segment in fewer, better capitalised importers. Reimbursement rules shape who can sell here more than in any other segment.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Registration holder | 14 | 39% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 35 | 97% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 3 | 8% | Registered with the US FDA as an exporter of devices made for export. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in South Korea
In South Korea the MFDS approval is held by a Korea Licence Holder, which is usually the importer. Changing importer means transferring or re-filing the approval, so many manufacturers appoint an independent holder.
This is the general rule, not legal advice. The registration clause in the first distributor contract decides who controls the market later. The Next 10 Markets report covers who holds the registration in each of your ten markets.
Questions about cardiovascular distributors in South Korea
How many cardiovascular distributors are there in South Korea?
The Index counts 36 establishments in South Korea with cardiovascular in their registry record, of which 0 are independent distributors (a channel role and no manufacturing of their own). The number comes from US FDA (openFDA), MHRA UK and Health Canada and was last refreshed on 23 October 2026.
Who can hold a cardiovascular device registration in South Korea?
In South Korea the MFDS approval is held by a Korea Licence Holder, which is usually the importer. Changing importer means transferring or re-filing the approval, so many manufacturers appoint an independent holder.
How do I find a cardiovascular distributor in South Korea?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and South Korea to see the top three names. For a ranked shortlist for your device, see the Next 10 Markets report.
What does the Distributor Index count as a cardiovascular distributor in South Korea?
A company that appears in a public regulatory registry with an address in South Korea and whose linked device listings fall in the cardiovascular segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
Other segments in South Korea
Cardiovascular in other Asia Pacific markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 35 establishments, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 17 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 14 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
Index build 23 October 2026. Each establishment is counted once per country after resolving names across sources. Company records only, as the registries publish them.
Registry data. Bastion Hale does not vouch for any establishment.