Updated 22 October 2026
In-vitro diagnostics distributors in South Korea: 83 licensed establishments
The Bastion Hale Distributor Index lists 83 establishments in South Korea whose registry records include in-vitro diagnostics: 2 with a channel role (importer, distributor, wholesaler or authorised representative), 11 registration holders without a channel role, and 70 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.
In-vitro diagnostics covers analysers, reagents, rapid tests and laboratory consumables across chemistry, haematology, microbiology, immunology and genetics. IVD has its own regulation in most markets, and the EU regulates it under IVDR rather than MDR. Laboratory distributors usually differ from device distributors, even inside the same company.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Distributor | 2 | 2% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 12 | 14% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 82 | 99% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 8 | 10% | 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 in-vitro diagnostics 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 | SUGENTECH, INC. Cheongju-si Chungbuk | Channel Distributor, Registration holder, Manufacturer | In-vitro diagnostics | 4 | 2 | 0 | 30.3 | 3/5 |
| 2 | SMILELAB CO., LTD. Seongnam-si Gyeonggi | Channel Distributor, Manufacturer, Exporter | In-vitro diagnostics | 2 | 1 | 0 | 22.4 | 3/5 |
| 3 | BODITECH MED INC. Chuncheon Gangwon | Holder Registration holder, Manufacturer | In-vitro diagnostics | 56 | 34 | 0 | 52.6 | 3/5 |
| 4 | NANOENTEK INC. Hwaseong Gyeonggi, GD | Holder Registration holder, Manufacturer | In-vitro diagnostics | 46 | 5 | 0 | 43.3 | 3/5 |
| 5 | Seegene Inc. Songpa-gu Seoul | Holder Registration holder, Manufacturer | Anaesthesia and respiratory, In-vitro diagnostics | 14 | 15 | 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 | I-SENS, INC. SEOUL | Holder Registration holder, Manufacturer | In-vitro diagnostics, Patient monitoring and neurology, Surgery and endoscopy | 23 | 7 | 0 | 41.2 | 3/5 |
| 8 | INFINITT HEALTHCARE CO., LTD. SEOUL | Holder Registration holder, Manufacturer | Cardiovascular, Dental, In-vitro diagnostics +1 more | 18 | 9 | 0 | 41.1 | 3/5 |
| 9 | SD Biosensor, Inc. Cheongju-si Chungbuk, GD | Holder Registration holder, Manufacturer | In-vitro diagnostics | 12 | 9 | 0 | 39.2 | 3/5 |
| 10 | OSANG Healthcare CO., LTD. ANYANG Gyeonggi, GD | Holder Registration holder, Manufacturer, Exporter | In-vitro diagnostics, Patient monitoring and neurology, Surgery and endoscopy | 17 | 2 | 0 | 36.8 | 3/5 |
| 11 | HLB LIFE SCIENCE CO., LTD. Anseong-si Gyeonggi, GD | Holder Registration holder, Manufacturer | General hospital and consumables, In-vitro diagnostics | 7 | 9 | 0 | 36.7 | 3/5 |
| 12 | Noul Co., Ltd. Yongin Si Gyeonggi, GD | Holder Registration holder, Manufacturer | In-vitro diagnostics | 6 | 3 | 0 | 31.7 | 3/5 |
| 13 | VPIX MEDICAL INCORPORATED Jung-gu Daejeon | Holder Registration holder, Manufacturer | Gastroenterology, urology and OB/GYN, In-vitro diagnostics, Patient monitoring and neurology +1 more | 6 | 3 | 0 | 31.7 | 3/5 |
| 14 | L&K BIOMED CO.,LTD. Yongin-SI Gyeonggi | Manufacturer Manufacturer, Exporter | In-vitro diagnostics, Patient monitoring and neurology, Orthopaedics, spine and trauma +1 more | 95 | 1 | 0 | 38.3 | 3/5 |
| 15 | OSUNG MND CO., LTD. Gimpo-si Gyeonggi | Manufacturer Manufacturer | Anaesthesia and respiratory, Dental, Ear, nose and throat +2 more | 67 | 1 | 0 | 34.3 | 3/5 |
| 16 | OSTEONIC CO., LTD. Seoul | Manufacturer Manufacturer, Exporter | Dental, In-vitro diagnostics, Patient monitoring and neurology +2 more | 38 | 1 | 0 | 33.8 | 3/5 |
| 17 | HI MEDICAL CO., LTD. SEOUL | Manufacturer Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +6 more | 45 | 1 | 0 | 32.3 | 3/5 |
| 18 | SPRINKLE CO., LTD. Yongin Gyeonggi | Manufacturer Manufacturer, Exporter | General hospital and consumables, Dental, Gastroenterology, urology and OB/GYN +3 more | 23 | 1 | 0 | 31.3 | 3/5 |
| 19 | i-SENS Wonju Factory Wonju-si Gangwon | Manufacturer Manufacturer | In-vitro diagnostics, Surgery and endoscopy | 22 | 1 | 0 | 28.8 | 3/5 |
| 20 | I-SENS Songdo Factory 2 lncheon Incheon | Manufacturer Manufacturer | In-vitro diagnostics, Surgery and endoscopy | 21 | 1 | 0 | 28.6 | 3/5 |
Questions about in-vitro diagnostics distributors in South Korea
How many in-vitro diagnostics distributors are there in South Korea?
The Index counts 83 establishments in South Korea with in-vitro diagnostics in their registry record, of which 2 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 in-vitro diagnostics 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 in-vitro diagnostics 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 in-vitro diagnostics 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 in-vitro diagnostics 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
In-vitro diagnostics in other Asia Pacific markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 83 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 12 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.