Data / Medical devices / Solution, Isotonic

Solution, Isotonic (JCE): 26 FDA-registered makers in 5 countries

Name: FDA-registered makers of Solution, Isotonic
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

26 establishments in 5 countries are registered with the FDA to make Solution, Isotonic (product code JCE, Class 1, 21 CFR 864.4010). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on September 11, 1984, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: JCE
Device class: 1
Regulation: 864.4010
Medical specialty: Pathology

Makers by country

Country	Makers
China	13
United States	10
Canada	1
Netherlands	1
Brazil	1

Makers of Solution, Isotonic

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	Source
Analytichem Usa, Inc.	Winslow, ME, United States	Manufacturer	api.fda.gov
Bestreat Safety & First Aid Solution Co., Ltd	Wuhan Hubei, China	Manufacturer	api.fda.gov
Chaptec America	Montreal Quebec, Canada	Manufacturer	api.fda.gov
Dongguan City Ruimi Gift Products Co Ltd	Dongguan Guangdong, China	Exporter to the US, Manufacturer	api.fda.gov
Fisher Diagnostics	Middletown, VA, United States	Manufacturer	api.fda.gov
Guangzhou Nuoning Medical Supplies Co.,ltd	Guangzhou Guangdong, China	Contract manufacturer, Manufacturer	api.fda.gov
Hangzhou Aosi Healthcare Co., Ltd.	HANGZHOU Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Hardy Diagnostics	Orcutt, CA, United States	Manufacturer	api.fda.gov
Hunan Pinliu Biological Technology Co., Ltd.	CHANGDE CITY Hunan, China	Exporter to the US, Manufacturer	api.fda.gov
Hardy Diagnostics	Springboro, OH, United States	Manufacturer	api.fda.gov
Hubei Lanbin Medical Group Co., Ltd.	Xiaogan City Hubei, China	Manufacturer	api.fda.gov
Michclone Associates, Inc.	Troy, MI, United States	Manufacturer	api.fda.gov
Nantong Kangjinchen Medical Equipment Co., Ltd.	Nantong Jiangsu, China	Manufacturer	api.fda.gov
Newcomer Supply Inc	Waunakee, WI, United States	Specification developer	api.fda.gov
Ningbo Tianbo First Aid Product Co., Ltd.	Ningbo Zhejiang, China	Manufacturer	api.fda.gov
Ricca Chemical Company LLC	Pocomoke City, MD, United States	Manufacturer	api.fda.gov
Ricca Chemical Company LLC	Arlington, TX, United States	Manufacturer	api.fda.gov
Ricca Chemical Company LLC	Batesville, IN, United States	Manufacturer	api.fda.gov
RR MECHATRONICS Manufacturing B.V.	ZWAAG Noord-Holland, Netherlands	Manufacturer	api.fda.gov
Saferlife Products Co.,ltd.	Guangzhou Guangdong, China	Contract manufacturer	api.fda.gov
Suzhou Pulikang Medical Device Co Ltd	Suzhou Jiangsu, China	Exporter to the US, Manufacturer	api.fda.gov
Taizhou Xinkang Medical Materials Co., Ltd	Taizhou Jiangsu, China	Contract manufacturer, Exporter to the US, Repackager or relabeler	api.fda.gov
Wavesense, Inc.	Irvine, CA, United States	Manufacturer	api.fda.gov
Yiwu Ori-Power Medtech Co., Ltd.	YIWU Zhejiang, China	Exporter to the US, Manufacturer	api.fda.gov
Zhejiang Changdi Medical Co., Ltd.	JINHUA Zhejiang, China	Contract manufacturer, Manufacturer	api.fda.gov
bioBoaVista	Valinhos Sao Paulo, Brazil	Manufacturer	api.fda.gov

Updated September 11, 1984. 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.