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Data / Medical devices / Cement, Stomal Appliance, Ostomy

Cement, Stomal Appliance, Ostomy (EZR): 20 FDA-registered makers in 5 countries

20 establishments in 5 countries are registered with the FDA to make Cement, Stomal Appliance, Ostomy (product code EZR, 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 6 510(k) clearances under this code, the latest on January 18, 1985, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
EZR
Device class
1
Regulation
876.5900
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States8
China7
United Kingdom3
Brazil1
Dominican Republic1

Makers of Cement, Stomal Appliance, Ostomy

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Andersonbrecon Inc.Rockford, IL, United StatesContract manufacturer0000api.fda.gov
Biomed Laboratories LLCDallas, TX, United StatesManufacturer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Casex, LtdaCuritiba Parana, BrazilManufacturer0000api.fda.gov
Cofoe Medical Technology Co.,ltdChangsha Hunan, ChinaManufacturer0000api.fda.gov
Convatec Dominican Republic, Inc.Haina San Cristobal, Dominican RepublicManufacturer0000api.fda.gov
Convatec LimitedDeeside Flintshire, United KingdomManufacturer0000api.fda.gov
ConvaTec Limited, GDC BuildingDeeside Flintshire, United KingdomSpecification developer0000api.fda.gov
Hangzhou Rollmed Co.,ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hollister IncorporatedLibertyville, IL, United StatesSpecification developer0000api.fda.gov
Hollister IncorporatedStuarts Draft, VA, United StatesManufacturer0000api.fda.gov
Hubei Hendry Medical Appliance Co., LtdXiaogan City Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Safe N Simple LLCClarkston, MI, United StatesManufacturer0000api.fda.gov
Safetec Of America, Inc.Buffalo, NY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Shaoxing Haoshide Medical Products Co.,ltdShaoxing Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Tongxiang Bao-Health Medical Instrument Co., Ltd.Tongxiang Zhejiang, ChinaManufacturer0000api.fda.gov
Trio Healthcare International LtdNorthampton Northamptonshire, United KingdomManufacturer0000api.fda.gov
Urocare Products, Inc.Pomona, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Zhende Medical Co., Ltd.SHAOXING Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov

Updated January 18, 1985. 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.