Updated 22 October 2026
Cardiovascular device distributors in South Korea: 35 licensed establishments
The Bastion Hale Distributor Index lists 35 establishments in South Korea whose registry records include cardiovascular: 0 with a channel role (importer, distributor, wholesaler or authorised representative), 14 registration holders without a channel role, and 21 registered as manufacturer or exporter only, out of 862 medical device establishments in South Korea overall. The records come from US FDA (openFDA) and Health Canada, last seen on 22 October 2026.
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 | 40% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 34 | 97% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 3 | 9% | 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.
Top 20 cardiovascular establishments by size
Channel roles first, then registration holders, then manufacturers. Size is a 0 to 100 score; Complete is 0 to 5.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | TAEWOONG MEDICAL CO., LTD Gimpo-Si Gyeonggi | Holder Registration holder, Manufacturer | Cardiovascular, Gastroenterology, urology and OB/GYN, Surgery and endoscopy | 77 | 15 | 0 | 50.5 | 3/5 |
| 2 | ALPINION MEDICAL SYSTEMS Co., Ltd. Gangseo-gu Seoul | Holder Registration holder, Manufacturer | Cardiovascular, Imaging, radiology and radiotherapy | 38 | 14 | 0 | 46.7 | 3/5 |
| 3 | Samsung Electronics Co., Ltd. Suwon-si Gyeonggi, GD | Holder Registration holder, Manufacturer | Cardiovascular, Patient monitoring and neurology, Imaging, radiology and radiotherapy | 38 | 13 | 0 | 46.3 | 3/5 |
| 4 | GE ULTRASOUND KOREA, LTD. Seongnam-Si Gyeonggi, GD | Holder Registration holder, Manufacturer | Cardiovascular, Imaging, radiology and radiotherapy | 38 | 12 | 0 | 46.0 | 3/5 |
| 5 | M.I. TECH CO., LTD. Pyeongtaek-Si, GD | Holder Registration holder, Manufacturer | Cardiovascular, Gastroenterology, urology and OB/GYN | 55 | 7 | 0 | 42.1 | 3/5 |
| 6 | INBODY CO., LTD. Cheonan-si Chungnam | Holder Registration holder, Manufacturer | Cardiovascular, General hospital and consumables, In-vitro diagnostics +3 more | 19 | 9 | 0 | 41.4 | 3/5 |
| 7 | INFINITT HEALTHCARE CO., LTD. SEOUL | Holder Registration holder, Manufacturer | Cardiovascular, Dental, In-vitro diagnostics +1 more | 18 | 9 | 0 | 41.1 | 3/5 |
| 8 | DAESUNG MAREF CO., LTD. Gunpo-si Gyeonggi | Holder Registration holder, Manufacturer | Cardiovascular, Patient monitoring and neurology, Surgery and endoscopy | 20 | 3 | 0 | 37.3 | 3/5 |
| 9 | MEDIANA CO., LTD. Wonju-Si, Gangwon-do | Holder Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +3 more | 20 | 3 | 0 | 37.3 | 3/5 |
| 10 | HUMANSCAN CO., LTD. Siheung-si Gyeonggi, GD | Holder Registration holder, Manufacturer | Cardiovascular, Imaging, radiology and radiotherapy | 20 | 2 | 0 | 35.9 | 3/5 |
| 11 | THE STANDARD CO., LTD. Gunpo-si Gyeonggi, GD | Holder Registration holder, Manufacturer | Cardiovascular, Gastroenterology, urology and OB/GYN, Ophthalmic +1 more | 14 | 3 | 0 | 35.6 | 3/5 |
| 12 | SEERS CO., LTD. Pyeongtaek Gyeonggi, GD | Holder Registration holder, Manufacturer | Cardiovascular, Patient monitoring and neurology | 7 | 2 | 0 | 31.0 | 3/5 |
| 13 | SELVAS Healthcare, Inc. Yuseong-gu Daejeon | Holder Registration holder, Manufacturer | Cardiovascular | 4 | 2 | 0 | 28.7 | 3/5 |
| 14 | XANDAR KARDIAN KOREA INC.. Seoul | Holder Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, Patient monitoring and neurology | 1 | 2 | 0 | 24.0 | 3/5 |
| 15 | Siemens Healthineers Ltd. SEONGNAM-SI Gyeonggi | Manufacturer Manufacturer | Cardiovascular, Imaging, radiology and radiotherapy | 96 | 2 | 0 | 38.0 | 3/5 |
| 16 | HI MEDICAL CO., LTD. SEOUL | Manufacturer Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +6 more | 45 | 1 | 0 | 32.3 | 3/5 |
| 17 | GENOSS Co., Ltd. Suwon-si Gyeonggi | Manufacturer Manufacturer | Cardiovascular, Dental | 29 | 1 | 0 | 30.2 | 3/5 |
| 18 | CUSTOM TUBE MANUFACTURING LLC Yangju-si Gyeonggi | Manufacturer Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +5 more | 23 | 1 | 0 | 29.0 | 3/5 |
| 19 | BIO PROTECH, INC. Wonju-si Gangwon | Manufacturer Manufacturer | Cardiovascular, General hospital and consumables, Gastroenterology, urology and OB/GYN +2 more | 22 | 1 | 0 | 28.8 | 3/5 |
| 20 | DREAMTECH CO., LTD. Asan-si Chungnam | Manufacturer Manufacturer, Exporter | Cardiovascular, General hospital and consumables, Patient monitoring and neurology +1 more | 12 | 1 | 0 | 28.2 | 3/5 |
Questions about cardiovascular distributors in South Korea
How many cardiovascular distributors are there in South Korea?
The Index counts 35 establishments in South Korea with cardiovascular in their registry record, of which 0 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from US FDA (openFDA) and Health Canada and was last refreshed on 22 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 reveal three profiles. For a ranked shortlist for your device, get 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: 34 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 14 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
Index build 22 October 2026. Each establishment is counted once per country after resolving names across sources. Named individuals are never collected.
Registry data. Bastion Hale does not vouch for any establishment.