Unit, Drying (JRJ): 18 FDA-registered makers in 8 countries

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

18 establishments in 8 countries are registered with the FDA to make Unit, Drying (product code JRJ, Class 1, 21 CFR 862.2050). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on July 24, 1979, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code: JRJ
Device class: 1
Regulation: 862.2050
Medical specialty: Clinical Chemistry

Makers by country

Country	Makers
United States	6
China	5
Mexico	2
South Korea	1
France	1
Turkey	1
Italy	1
Netherlands	1

Makers of Unit, Drying

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	Recall events	Source
Aspen Surgical Products, Inc.	Caledonia, MI, United States	Specification developer	0	api.fda.gov
Boen Healthcare Co., Ltd.	Suzhou Jiangsu, China	Exporter to the US, Specification developer	0	api.fda.gov
Capsa Healthcare	Canal Winchester, OH, United States	Manufacturer	0	api.fda.gov
Cenorin, LLC	Kent, WA, United States	Manufacturer	1	api.fda.gov
Diatrust Medical Co., Ltd.	Nanjing City Jiangsu, China	Manufacturer	0	api.fda.gov
Infitek Co., Ltd.	Shanghai, China	Manufacturer	0	api.fda.gov
Industrias Apson S.A de C.V	AGUA PRIETA Sonora, Mexico	Contract manufacturer	0	api.fda.gov
International Manufacturing Solutions Operaciones	Cd. Juarez Chihuahua, Mexico	Manufacturer, Repackager or relabeler	0	api.fda.gov
Labpeak Co.,ltd	Jinan Shandong, China	Exporter to the US, Manufacturer	0	api.fda.gov
Medihub Co., Ltd.	Gunpo-si Gyeonggi, South Korea	Manufacturer	0	api.fda.gov
MG Developpement	mauguio Herault, France	Exporter to the US, Manufacturer	0	api.fda.gov
MG Development America Inc.	Pittsburgh, PA, United States	Manufacturer	0	api.fda.gov
Nuve Sanayi Malzemeleri Imalat Ve Ticaret A.S.	Ankara, Turkey	Manufacturer	0	api.fda.gov
Scitek Global Co.,ltd	Jinan Shandong, China	Exporter to the US, Manufacturer	0	api.fda.gov
Sheldon MFG., Inc.	Cornelius, OR, United States	Manufacturer	0	api.fda.gov
Steelco S.P.A.	Riese Pio X Treviso, Italy	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Wassenburg Medical B.V.	Dodewaard Gelderland, Netherlands	Contract manufacturer	0	api.fda.gov
Wassenburg Medical, Inc.	Ivyland, PA, United States	Manufacturer, Specification developer	0	api.fda.gov

Updated July 24, 1979. 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.