Data / Medical devices / Bag, Urine Collecting, Ureterostomy

Bag, Urine Collecting, Ureterostomy (EXG): 39 FDA-registered makers in 10 countries

Name: FDA-registered makers of Bag, Urine Collecting, Ureterostomy
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

39 establishments in 10 countries are registered with the FDA to make Bag, Urine Collecting, Ureterostomy (product code EXG, Class 1, 21 CFR 876.5900). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code: EXG
Device class: 1
Regulation: 876.5900
Medical specialty: Gastroenterology, Urology

Makers by country

Country	Makers
China	22
United States	7
United Kingdom	2
India	2
Brazil	1
Dominican Republic	1
Germany	1
Ireland	1
Mexico	1
Egypt	1

Makers of Bag, Urine Collecting, Ureterostomy

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
Boen Healthcare Co., Ltd.	Suzhou Jiangsu, China	Exporter to the US, Specification developer	api.fda.gov
Casex, Ltda	Curitiba Parana, Brazil	Manufacturer	api.fda.gov
Concarey Medical Technology Co., Ltd	Shanghai, China	Exporter to the US, Manufacturer	api.fda.gov
Convatec Dominican Republic, Inc.	Haina San Cristobal, Dominican Republic	Manufacturer	api.fda.gov
Convatec Limited	Deeside Flintshire, United Kingdom	Manufacturer	api.fda.gov
ConvaTec Limited, GDC Building	Deeside Flintshire, United Kingdom	Specification developer	api.fda.gov
Cook Incorporated	Bloomington, IN, United States	Complaint file establishment, Manufacturer	api.fda.gov
Cook Incorporated	Spencer, IN, United States	Manufacturer	api.fda.gov
Disposafe Health And Life Care Limited	Faridabad Haryana, India	Contract manufacturer, Manufacturer	api.fda.gov
Dongguan Kangda Medical Technology Co., Ltd	Dongguan Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
For Life GMBH	Berlin, Germany	Manufacturer	api.fda.gov
Hangzhou Rollmed Co.,ltd.	Hangzhou Zhejiang, China	Contract manufacturer, Manufacturer	api.fda.gov
Henan Maidingkang Medical Technology Co., Ltd.	Changyuan Henan, China	Manufacturer, Repackager or relabeler	api.fda.gov
Hollister Incorporated	Libertyville, IL, United States	Specification developer	api.fda.gov
Hollister Incorporated	Stuarts Draft, VA, United States	Manufacturer	api.fda.gov
Hollister ULC	REHINS BALLINA Mayo, Ireland	Manufacturer	api.fda.gov
Heuer International (A division of GST Corporation Limited)	NOIDA Uttar Pradesh, India	Foreign private label distributor, Manufacturer, Repackager or relabeler	api.fda.gov
Industrias Plasticas Medicas, S.A. De C.V.	Ayala Morelos, Mexico	Manufacturer	api.fda.gov
Jiangsu Ostup Medical Products Co. Ltd.	Nanjing Jiangsu, China	Exporter to the US, Manufacturer	api.fda.gov
Jiangsu Hongsheng Bioengineering Co., Ltd.	Nantong Jiangsu, China	Exporter to the US, Manufacturer	api.fda.gov
Jiangxi Yiles Medical Co., Ltd	Nanchang City Jiangxi, China	Manufacturer	api.fda.gov
Lianyungang Aoke Medical Equipment Co.,ltd.	Lianyungang Jiangsu, China	Manufacturer	api.fda.gov
Marlen MFG. & Development Co.	Bedford, OH, United States	Manufacturer	api.fda.gov
Nan'an Hengyuan Hygiene Products Co., Ltd.	Nanan Fujian, China	Exporter to the US, Manufacturer	api.fda.gov
Ningbo Chibanda Imp &exp Co, Ltd	Ningbo Zhejiang, China	Manufacturer	api.fda.gov
Ningbo Risenmed Technology Co.,ltd.	Ningbo Zhejiang, China	Manufacturer	api.fda.gov
Ningbo Great Mountain Medical Instruments Co.,Ltd	Ningbo Zhejiang, China	Contract manufacturer, Manufacturer	api.fda.gov
Pharmaplast S.A.E.	ALEXANDRIA Al Iskandariyah, Egypt	Contract manufacturer, Manufacturer	api.fda.gov
Rusun Medical Co., Ltd	Yichun City Jiangxi, China	Manufacturer	api.fda.gov
Sarasota Medical Products	Sarasota, FL, United States	Contract manufacturer, Manufacturer	api.fda.gov
Shanghai Lions Industrial Co.,ltd.	Shanghai, China	Contract manufacturer, Exporter to the US	api.fda.gov
Syncro Medical Innovations, Inc.	Macon, GA, United States	Specification developer	api.fda.gov
Shanghai Jolly Industrial Co., Ltd.	Shanghai, China	Contract manufacturer, Exporter to the US	api.fda.gov
Shijiazhuang Yide Medical Device Manufacturing Co., Ltd.	Shijiazhuang City Hebei, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Tongxiang Bao-Health Medical Instrument Co., Ltd.	Tongxiang Zhejiang, China	Manufacturer	api.fda.gov
Tuper Medical Co., Ltd.	Dezhou City Shandong, China	Exporter to the US, Manufacturer	api.fda.gov
Wenzhou Celecare Medical lnstruments Co.,Ltd.	wenzhou Zhejiang, China	Manufacturer	api.fda.gov
Zhejiang Anji Huabu Industrial Co., Ltd.	HUZHOU Zhejiang, China	Manufacturer	api.fda.gov
ZHEJIANG Ailebao MEDICAL TECHNOLOGY CO., LTD	Wenzhou Zhejiang, China	Exporter to the US, Manufacturer	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.