Updated 22 October 2026
In-vitro diagnostics distributors in South Korea: 84 licensed establishments
The Bastion Hale Distributor Index lists 84 establishments in South Korea whose registry records include in-vitro diagnostics: 0 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 2 manufacturers' own import or sales entities, 0 regulatory representatives, and 82 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.
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 | 13 | 15% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 83 | 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 0 independent in-vitro diagnostics distributors
Independent distributors only, ranked by the other manufacturers' lines they carry, then registrations held, then size.
No independent distributor is registered here yet; every establishment on record is a manufacturer or a manufacturer's own sales entity.
Include manufacturers, their own sales entities and regulatory representatives (84)
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.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | SUGENTECH, INC. Cheongju-si Chungbuk | Maker's own entity Distributor, Registration holder, Manufacturer | In-vitro diagnostics | 4 | 2 | 0 | 30.3 | 3/5 |
| 2 | SMILELAB CO., LTD. Seongnam-si Gyeonggi | Maker's own entity Distributor, Manufacturer, Exporter | In-vitro diagnostics | 2 | 1 | 0 | 22.4 | 3/5 |
| 3 | SD Biosensor, Inc. Cheongju-si Chungbuk, GD | Manufacturer Registration holder, Manufacturer | In-vitro diagnostics | 35 | 44 | 0 | 53.8 | 3/5 |
| 4 | Seegene Inc. Songpa-gu Seoul | Manufacturer Registration holder, Manufacturer | Anaesthesia and respiratory, In-vitro diagnostics | 29 | 44 | 0 | 52.9 | 3/5 |
| 5 | BODITECH MED INC. Chuncheon Gangwon | Manufacturer Registration holder, Manufacturer | In-vitro diagnostics | 56 | 42 | 0 | 55.9 | 3/5 |
| 6 | I-SENS, INC. SEOUL | Manufacturer Registration holder, Manufacturer | In-vitro diagnostics, Patient monitoring and neurology, Surgery and endoscopy | 23 | 14 | 0 | 46.6 | 3/5 |
| 7 | BIONEER CORPORATION Yuseong-gu Daejeon | Manufacturer Manufacturer | In-vitro diagnostics | 11 | 12 | 0 | 37.7 | 3/5 |
| 8 | INBODY CO., LTD. Cheonan-si Chungnam | Manufacturer Registration holder, Manufacturer | Cardiovascular, General hospital and consumables, In-vitro diagnostics +3 more | 19 | 10 | 0 | 44.2 | 3/5 |
| 9 | INFINITT HEALTHCARE CO., LTD. SEOUL | Manufacturer Registration holder, Manufacturer | Cardiovascular, Dental, In-vitro diagnostics +1 more | 18 | 9 | 0 | 43.5 | 3/5 |
| 10 | HLB LIFE SCIENCE CO., LTD. Anseong-si Gyeonggi, GD | Manufacturer Registration holder, Manufacturer | General hospital and consumables, In-vitro diagnostics | 7 | 9 | 0 | 36.7 | 3/5 |
| 11 | MEDIANA CO., LTD. Wonju-Si, Gangwon-do, Gangwon-do | Manufacturer Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +5 more | 20 | 8 | 0 | 43.5 | 3/5 |
| 12 | NANOENTEK INC. Hwaseong Gyeonggi, GD | Manufacturer Registration holder, Manufacturer | In-vitro diagnostics | 46 | 6 | 0 | 46.4 | 3/5 |
| 13 | Noul Co., Ltd. Yongin Si Gyeonggi, GD | Manufacturer Registration holder, Manufacturer | In-vitro diagnostics | 6 | 4 | 0 | 35.2 | 3/5 |
| 14 | VPIX MEDICAL INCORPORATED Jung-gu Daejeon, Daejeon | Manufacturer Registration holder, Manufacturer | Gastroenterology, urology and OB/GYN, In-vitro diagnostics, Patient monitoring and neurology +1 more | 6 | 4 | 0 | 35.2 | 3/5 |
| 15 | OSANG Healthcare CO., LTD. ANYANG Gyeonggi, GD | Manufacturer Registration holder, Manufacturer, Exporter | In-vitro diagnostics, Patient monitoring and neurology, Surgery and endoscopy | 17 | 3 | 0 | 40.5 | 3/5 |
| 16 | OSTEONIC CO., LTD. Seoul | Manufacturer Manufacturer, Exporter | Dental, In-vitro diagnostics, Patient monitoring and neurology +2 more | 38 | 3 | 0 | 40.4 | 3/5 |
| 17 | DFI CO., LTD. Gimhae Jeonnam, Gyeongsangnam-do | Manufacturer Manufacturer | In-vitro diagnostics | 2 | 3 | 0 | 25.2 | 3/5 |
| 18 | HANWOOLTPC Co., Ltd. Bucheon Gyeonggi, Bucheon-si, | Manufacturer Manufacturer | In-vitro diagnostics | 1 | 2 | 0 | 21.8 | 3/5 |
| 19 | 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 |
| 20 | OSUNG MND CO., LTD. Gimpo-si Gyeonggi | Manufacturer Manufacturer | Anaesthesia and respiratory, Dental, Ear, nose and throat +2 more | 67 | 1 | 0 | 37.7 | 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 84 establishments in South Korea with in-vitro diagnostics 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 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: 84 establishments, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 22 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 13 establishments, last seen 23 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.