Data / Medical devices / Analyzer, Chemistry (Photometric, Discrete), For Clinical Use / Japan

FDA-registered makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use in Japan: 21 establishments

Name: FDA-registered makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use in Japan
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

21 establishments in Japan are registered with the FDA to make Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (product code JJE). 3 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.

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Device: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Product code: JJE
Country: Japan

Makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use in Japan

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Beckman Coulter K. K.	Sunto-Gun Shizuoka, Japan	Specification developer	1	July 5, 1996	0	api.fda.gov
Biolis Medical Corp.	Hino Tokyo, Japan	Manufacturer	1	February 15, 2005	0	api.fda.gov
Horiba Ltd.	Kyoto, Japan	Contract manufacturer, Exporter to the US, Specification developer	1	February 12, 2019	0	api.fda.gov
Beckman Coulter Mishima K.K.	SUNTO-GUN Shizuoka, Japan	Contract manufacturer	0		4	api.fda.gov
Canon Inc.	OTAWARA-SHI Tochigi, Japan	Contract manufacturer	0		0	api.fda.gov
Fandf Co., Ltd. Medical Device Department	Hachioji-shi Tokyo, Japan	Contract manufacturer	0		0	api.fda.gov
Furuno Electric Co., Ltd.	NISHINOMIYA-CITY Hyogo, Japan	Manufacturer	0		0	api.fda.gov
Fujirebio Inc.	Sagamihara-shi Kanagawa, Japan	Manufacturer	0		0	api.fda.gov
Fujirebio Inc. Ube Facility	Yamaguchi, Japan	Manufacturer	0		0	api.fda.gov
Hitachi High-Tech Corp., Naka Division	Hitachinaka-shi Ibaraki, Japan	Contract manufacturer	0		0	api.fda.gov
Hitachi High-Tech Corp., Omuta Center	Omuta-shi Fukuoka, Japan	Contract manufacturer	0		0	api.fda.gov
Ids Co, Ltd	Kumamoto-Shi, Japan	Contract manufacturer	0		0	api.fda.gov
Jeol Ltd.	Musashimurayama Tokyo, Japan	Manufacturer	0		0	api.fda.gov
Kikuyo Factory	Kumamoto, Japan	Manufacturer	0		0	api.fda.gov
Otsuka Electronics Co., Ltd.	Koka-city Shiga, Japan	Contract manufacturer	0		0	api.fda.gov
PHC Corporation	Tako-machi Katori-gun Chiba, Japan	Complaint file establishment, Specification developer	0		0	api.fda.gov
Precision System Science Company Limited	Matsudo-city Chiba, Japan	Contract manufacturer	0		0	api.fda.gov
Sysmex Corporation	KOBE Hyogo, Japan	Manufacturer	0		0	api.fda.gov
Sysmex Corporation Techno Park	KOBE Hyogo, Japan	Specification developer	0		0	api.fda.gov
Tosoh Hi-Tec, Inc.	Yamaguchi, Japan	Manufacturer	0		0	api.fda.gov
Yamura Electric Industry Co., Ltd.	KITAKAMI-SHI Iwate, Japan	Contract manufacturer	0		0	api.fda.gov

Updated November 3, 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.