Data / Medical devices / Calibrator, Primary / Japan
FDA-registered makers of Calibrator, Primary in Japan: 8 establishments
8 establishments in Japan are registered with the FDA to make Calibrator, Primary (product code JIS). 3 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Calibrator, Primary
- Product code
- JIS
- Country
- Japan
Makers of Calibrator, Primary in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| FUJIFILM Healthcare Manufacturing Corporation MIE Office | Komono-cho, Mie-gun, Japan | Manufacturer | 3 | April 11, 2003 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki) | Amagasaki-shi Hyogo, Japan | Specification developer | 3 | April 11, 2003 | 0 | 0 | 0 | api.fda.gov |
| Denka Co., Ltd. | GOSEN-SHI Niigata, Japan | Manufacturer | 1 | June 2, 2003 | 0 | 0 | 0 | api.fda.gov |
| Nittobo Medical Co., Ltd. Medical Development Center | Koriyama Fukushima, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SEKISUI MEDICAL CO., LTD. Tsukuba Plant | Ryugasaki-shi Ibaraki, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Takasaki Plant, Nippon Kayaku Co., Ltd. | TAKASAKI-SHI Gunma, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tosoh Aia, Inc. | Toyama, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tosoh Hi-Tec, Inc. | Yamaguchi, Japan | 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.