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Data / Medical devices / Appliance, Colostomy, Disposable

Appliance, Colostomy, Disposable (EZS): 21 FDA-registered makers in 7 countries

21 establishments in 7 countries are registered with the FDA to make Appliance, Colostomy, Disposable (product code EZS, 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 1 510(k) clearance under this code, the latest on April 27, 1978, 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
EZS
Device class
1
Regulation
876.5900
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States8
China7
United Kingdom2
Brazil1
Dominican Republic1
Canada1
Egypt1

Makers of Appliance, Colostomy, Disposable

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
3M CompanySaint Paul, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
3M CompanyBrookings, SD, United StatesManufacturer0000api.fda.gov
Amsino Medical (kunshan) Co., Ltd.KUNSHAN CITY Jiangsu, ChinaContract manufacturer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Casex, LtdaCuritiba Parana, BrazilManufacturer0000api.fda.gov
Convatec Dominican Republic, Inc.Haina San Cristobal, Dominican RepublicManufacturer0000api.fda.gov
Colo-Majic Enterprises LTDMaple Ridge British Columbia, CanadaSpecification developer0000api.fda.gov
ConvaTec Limited, GDC BuildingDeeside Flintshire, United KingdomSpecification developer0000api.fda.gov
Fistula Solution CorporationScandia, MN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Hangzhou Rollmed Co.,ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hollister IncorporatedLibertyville, IL, United StatesSpecification developer0000api.fda.gov
Hubei Hendry Medical Appliance Co., LtdXiaogan City Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Marlen MFG. & Development Co.Bedford, OH, United StatesManufacturer0000api.fda.gov
Ningbo Kehu Medical Technology Co.,ltd.Ningbo Zhejiang, ChinaForeign private label distributor, Specification developer0000api.fda.gov
Pharmaplast S.A.E.ALEXANDRIA Al Iskandariyah, EgyptContract manufacturer, Manufacturer0000api.fda.gov
Safe N Simple LLCClarkston, MI, United StatesManufacturer0000api.fda.gov
Salts Healthcare LimitedAston Birmingham, United KingdomContract manufacturer, Manufacturer0000api.fda.gov
Sarasota Medical ProductsSarasota, FL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Tongxiang Bao-Health Medical Instrument Co., Ltd.Tongxiang Zhejiang, ChinaManufacturer0000api.fda.gov
Versipel, LLCDunmore, PA, United StatesSpecification developer0000api.fda.gov
Zhejiang Mediunion Healthcare Group Co.,ltdNingbo Zhejiang, ChinaManufacturer0000api.fda.gov

Updated April 27, 1978. 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.