Data / Medical devices / Labware, Assisted Reproduction, Exempt / Japan
FDA-registered makers of Labware, Assisted Reproduction, Exempt in Japan: 7 establishments
7 establishments in Japan are registered with the FDA to make Labware, Assisted Reproduction, Exempt (product code PUD). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Labware, Assisted Reproduction, Exempt
- Product code
- PUD
- Country
- Japan
Makers of Labware, Assisted Reproduction, Exempt in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| ASTEC CO., Ltd. | Kasuya Fukuoka, Japan | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Akita Sumitomo Bakelite Co., Ltd. | Akita, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kanto Gosei Kogyo Co.,ltd. | Sumida-ku Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kitazato Corporation | Fuji Shizuoka, Japan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Omura Kogyo Co., Ltd. Hara Factory | Numazu Shizuoka, Japan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Reprolife Inc. | Shinjuku-ku Tokyo, Japan | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yasui Co., Ltd. | Higashiusuki-gun Miyazaki, Japan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.