Updated 22 October 2026
Gastroenterology and urology device distributors in Japan: 81 licensed establishments
The Bastion Hale Distributor Index lists 81 establishments in Japan whose registry records include gastroenterology, urology and ob/gyn: 0 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 1 manufacturers' own import or sales entities, 0 regulatory representatives, and 80 manufacturers or exporters, out of 568 medical device establishments in Japan overall. The records come from US FDA (openFDA), MHRA UK and Health Canada, last seen on 23 October 2026.
Gastroenterology, urology and obstetrics covers flexible endoscopy accessories, lithotripsy, dialysis, catheters and women's health devices. Dialysis consumables bring large recurring volumes and a few dominant players. The rest of the segment is spread across many mid-sized importers.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Distributor | 1 | 1% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 10 | 12% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 75 | 93% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 19 | 23% | 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 Japan
In Japan the marketing approval or certification is held by a Marketing Authorisation Holder (MAH) based in Japan, or by a Designated MAH acting for a foreign manufacturer. The foreign manufacturer registers separately with PMDA. An independent D-MAH keeps the approval out of the distributor's hands.
Top 0 independent gastroenterology, urology and ob/gyn 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 (81)
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 | Daiso Industries Co., Ltd. Higashihiroshima | Maker's own entity Distributor, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Dental +5 more | 34 | 1 | 0 | 34.8 | 3/5 |
| 2 | OLYMPUS MEDICAL SYSTEMS CORP. HACHIOJI-SHI Tokyo, Hachioji-shi | Manufacturer Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 351 | 229 | 0 | 74.0 | 3/5 |
| 3 | CANON INC. Kawasaki Kanagawa | Manufacturer Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +8 more | 673 | 129 | 0 | 73.7 | 3/5 |
| 4 | FUJIFILM CORPORATION ASHIGARAKAMI-GUN Kanagawa | Manufacturer Registration holder, Manufacturer | Cardiovascular, General hospital and consumables, Gastroenterology, urology and OB/GYN +4 more | 163 | 87 | 0 | 64.7 | 3/5 |
| 5 | PENTAX MEDICAL CORPORATION Tokyo | Manufacturer Registration holder, Manufacturer | Cardiovascular, Ear, nose and throat, Gastroenterology, urology and OB/GYN +2 more | 52 | 51 | 0 | 54.1 | 3/5 |
| 6 | TERUMO CORPORATION SHIBUYA-KU, TOKYO | Manufacturer Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +4 more | 69 | 35 | 0 | 57.8 | 3/5 |
| 7 | NIHON KOHDEN CORPORATION SHINJUKU-KU Tokyo, Tokyo | Manufacturer Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 92 | 33 | 0 | 57.3 | 3/5 |
| 8 | ASAHI INTECC CO., LTD. SETO Aichi, Aichi | Manufacturer Registration holder, Manufacturer | Cardiovascular, Gastroenterology, urology and OB/GYN, Patient monitoring and neurology | 79 | 31 | 0 | 56.3 | 3/5 |
| 9 | NIPRO CORPORATION Settsu Osaka | Manufacturer Registration holder, Manufacturer, Exporter | Cardiovascular, General hospital and consumables, Dental +4 more | 51 | 30 | 0 | 55.5 | 3/5 |
| 10 | Kitazato Corporation Minato-ku Tokyo, Shizuoka | Manufacturer Registration holder, Manufacturer, Exporter | Cardiovascular, General hospital and consumables, Gastroenterology, urology and OB/GYN | 32 | 12 | 0 | 49.1 | 3/5 |
| 11 | PHC Corporation TOON Ehime, Gunma | Manufacturer Manufacturer, Exporter | Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 49 | 11 | 0 | 46.9 | 3/5 |
| 12 | FUKUDA DENSHI CO., LTD. Bunkyo-ku Tokyo | Manufacturer Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +1 more | 33 | 8 | 0 | 41.3 | 3/5 |
| 13 | ASTEC CO., Ltd. Kasuya Fukuoka | Manufacturer Manufacturer | Gastroenterology, urology and OB/GYN | 3 | 4 | 0 | 27.7 | 3/5 |
| 14 | Unisis Corporation Koshigaya-shi Saitama | Manufacturer Manufacturer | Anaesthesia and respiratory, General hospital and consumables, Gastroenterology, urology and OB/GYN +1 more | 23 | 3 | 0 | 35.7 | 3/5 |
| 15 | HOYA Corporation PENTAX Lifecare Division KURIHARA-SHI Miyagi | Manufacturer Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Ear, nose and throat +3 more | 154 | 2 | 0 | 42.7 | 3/5 |
| 16 | EIZO CORPORATION HAKUSAN Ishikawa, Ishikawa | Manufacturer Manufacturer | Gastroenterology, urology and OB/GYN, In-vitro diagnostics, Imaging, radiology and radiotherapy +1 more | 35 | 2 | 0 | 36.4 | 3/5 |
| 17 | OKAMOTO INDUSTRIES, INC. RYUGASAKI-SHI, IBARAKI-PREF | Manufacturer Registration holder, Manufacturer, Exporter | Gastroenterology, urology and OB/GYN, Patient monitoring and neurology | 8 | 2 | 0 | 33.2 | 3/5 |
| 18 | Sony Corporation Yokohama-shi Kanagawa | Manufacturer Manufacturer | Gastroenterology, urology and OB/GYN, Imaging, radiology and radiotherapy, Surgery and endoscopy | 16 | 2 | 0 | 32.6 | 3/5 |
| 19 | Evident Corporation Hachioji-shi Tokyo | Manufacturer Manufacturer | Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 10 | 2 | 0 | 30.4 | 3/5 |
| 20 | NIKON CORPORATION SHINAGAWA-KU Tokyo | Manufacturer Manufacturer | Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 5 | 2 | 0 | 27.3 | 3/5 |
Questions about gastroenterology, urology and ob/gyn distributors in Japan
How many gastroenterology, urology and ob/gyn distributors are there in Japan?
The Index counts 81 establishments in Japan with gastroenterology, urology and ob/gyn 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 gastroenterology, urology and ob/gyn device registration in Japan?
In Japan the marketing approval or certification is held by a Marketing Authorisation Holder (MAH) based in Japan, or by a Designated MAH acting for a foreign manufacturer. The foreign manufacturer registers separately with PMDA. An independent D-MAH keeps the approval out of the distributor's hands.
How do I find a gastroenterology, urology and ob/gyn distributor in Japan?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Japan 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 gastroenterology, urology and ob/gyn distributor in Japan?
A company that appears in a public regulatory registry with an address in Japan and whose linked device listings fall in the gastroenterology, urology and ob/gyn segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
Other segments in Japan
Gastroenterology, urology and OB/GYN in other Asia Pacific markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 80 establishments, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 24 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 10 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.