Updated 22 October 2026
ENT device distributors in South Korea: 43 licensed establishments
The Bastion Hale Distributor Index lists 43 establishments in South Korea whose registry records include ear, nose and throat: 1 with a channel role (importer, distributor, wholesaler or authorised representative), 5 registration holders without a channel role, and 37 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.
Ear, nose and throat covers hearing devices, cochlear implants, sinus and laryngology instruments, and audiology equipment. Hearing aids often go through retail audiology chains rather than hospital distributors, so the establishment list mixes both. Volumes per establishment are smaller than in surgery.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Distributor | 1 | 2% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 6 | 14% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 42 | 98% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 4 | 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 ear, nose and throat 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 | OSSTEM IMPLANT CO., LTD. Haeundae-gu Busan, GD | Channel Distributor, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Dental, Ear, nose and throat +3 more | 358 | 41 | 0 | 65.6 | 3/5 |
| 2 | DIO Corporation Haeundae-gu Busan | Holder Registration holder, Manufacturer, Exporter | Dental, Ear, nose and throat, Orthopaedics, spine and trauma +2 more | 202 | 27 | 0 | 59.6 | 3/5 |
| 3 | JEIL MEDICAL CORPORATION Seoul | Holder Registration holder, Manufacturer | General hospital and consumables, Dental, Ear, nose and throat +4 more | 128 | 12 | 0 | 52.0 | 3/5 |
| 4 | DENTIUM CO., LTD. Suwon-si Gyeonggi | Holder Registration holder, Manufacturer | Dental, Ear, nose and throat, Orthopaedics, spine and trauma +1 more | 87 | 10 | 0 | 49.3 | 3/5 |
| 5 | COWELLMEDI CO., LTD. BUSAN | Holder Registration holder, Manufacturer | Dental, Ear, nose and throat, Orthopaedics, spine and trauma +1 more | 79 | 6 | 0 | 46.7 | 3/5 |
| 6 | 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 |
| 7 | Chun Ahn Logistics Guiheung-GU Yongin-Si, Kyunggi-DO Gyeonggi | Manufacturer Exporter | General hospital and consumables, Ear, nose and throat, Gastroenterology, urology and OB/GYN +2 more | 100 | 1 | 0 | 36.3 | 3/5 |
| 8 | Dental Studio Co., Ltd. Anyang-si Gyeonggi, Gyeonggi-Do | Manufacturer Manufacturer | Dental, Ear, nose and throat, Surgery and endoscopy | 27 | 2 | 0 | 35.1 | 3/5 |
| 9 | 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 |
| 10 | 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 |
| 11 | MCTBIO Yongin-si Gyeonggi | Manufacturer Manufacturer | General hospital and consumables, Dental, Ear, nose and throat +3 more | 20 | 1 | 0 | 28.4 | 3/5 |
| 12 | DMED Seongnam-si Gyeonggi | Manufacturer Manufacturer | General hospital and consumables, Ear, nose and throat, Gastroenterology, urology and OB/GYN +2 more | 19 | 1 | 0 | 28.1 | 3/5 |
| 13 | HDI INC. Seongnam-si Gyeonggi | Manufacturer Manufacturer | Anaesthesia and respiratory, General hospital and consumables, Dental +1 more | 17 | 1 | 0 | 27.6 | 3/5 |
| 14 | NEOMED CO., LTD. Saha-gu Busan | Manufacturer Manufacturer | General hospital and consumables, Dental, Ear, nose and throat +2 more | 16 | 1 | 0 | 27.3 | 3/5 |
| 15 | SMENG CO.,LTD. Busan | Manufacturer Manufacturer | General hospital and consumables, Dental, Ear, nose and throat +4 more | 14 | 1 | 0 | 26.7 | 3/5 |
| 16 | FINEMEDIX Daegu Gwangyeogsi | Manufacturer Manufacturer | Ear, nose and throat, Gastroenterology, urology and OB/GYN | 12 | 1 | 0 | 25.9 | 3/5 |
| 17 | AIOBIO CO., LTD. Seongnam-si Gyeonggi | Manufacturer Manufacturer, Exporter | General hospital and consumables, Dental, Ear, nose and throat +1 more | 7 | 1 | 0 | 25.7 | 3/5 |
| 18 | EVERAID CO., LTD. YANGSAN-SI Gyeongnam | Manufacturer Manufacturer | General hospital and consumables, Ear, nose and throat, Patient monitoring and neurology +1 more | 10 | 1 | 0 | 25.1 | 3/5 |
| 19 | Samsung Electronics Co., Ltd. Mobile eXperience Business Suwon-si Gyeonggi | Manufacturer Manufacturer | Anaesthesia and respiratory, Cardiovascular, Ear, nose and throat | 7 | 1 | 0 | 23.5 | 3/5 |
| 20 | MEDICORE CO., LTD. Seongnam-si Gyeonggi | Manufacturer Manufacturer | Cardiovascular, Ear, nose and throat, Gastroenterology, urology and OB/GYN | 4 | 2 | 0 | 23.0 | 3/5 |
Questions about ear, nose and throat distributors in South Korea
How many ear, nose and throat distributors are there in South Korea?
The Index counts 43 establishments in South Korea with ear, nose and throat in their registry record, of which 1 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 ear, nose and throat 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 ear, nose and throat 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 ear, nose and throat 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 ear, nose and throat 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
Ear, nose and throat in other Asia Pacific markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 43 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 7 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.