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Data / Medical devices / Protector, Ostomy

Protector, Ostomy (EXE): 55 FDA-registered makers in 13 countries

55 establishments in 13 countries are registered with the FDA to make Protector, Ostomy (product code EXE, Class 1, 21 CFR 876.5900). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on March 6, 1991, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.

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

Makers by country

CountryMakers
China29
United States8
United Kingdom7
Taiwan2
Brazil1
Dominican Republic1
Pakistan1
Lithuania1
Turkey1
Ireland1
Mexico1
Denmark1
Slovakia1

Makers of Protector, 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
Anji Spenq Industrial Co., Ltd.Huzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Austin Medical Products, Inc.Portland, ME, United StatesManufacturer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Casex, LtdaCuritiba Parana, BrazilManufacturer0000api.fda.gov
Clinical Polymer Technologies LtdCoalville Leicestershire, United KingdomContract manufacturer0000api.fda.gov
Cofoe Medical Technology Co.,ltdChangsha Hunan, ChinaManufacturer0000api.fda.gov
Concarey Medical Technology Co., LtdShanghai, ChinaExporter to the US, Manufacturer0000api.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
Euromed, Inc.Orangeburg, NY, United StatesContract manufacturer0000api.fda.gov
Fortune Medical Instrument Corp.Taoyuan City, TaiwanManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Gbuk Group LimitedSelby North Yorkshire, United KingdomSpecification developer0000api.fda.gov
Haiyan Kangyuan Medical Instrument Co.,ltd.JiaXing Zhejiang, ChinaContract manufacturer0000api.fda.gov
Hangzhou Rollmed Co.,ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Henso Medical (hangzhou) Co.,ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Hollister IncorporatedLibertyville, IL, United StatesSpecification developer0000api.fda.gov
Hollister IncorporatedStuarts Draft, VA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Hubei Hendry Medical Appliance Co., LtdXiaogan City Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Huida Biopharmaceuticals (suzhou) LtdSUZHOU Jiangsu, ChinaContract manufacturer0000api.fda.gov
Huzhou Junda Industry Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hangzhou Fushan Medical Appliance Co., Ltd.Hangzhou City Zhejiang, ChinaContract manufacturer0000api.fda.gov
Heaven Healthcare Co., Ltd.Shaoxing Zhejiang, ChinaManufacturer0000api.fda.gov
Hollister Lietuva UABKaunas district, LithuaniaContract manufacturer, Manufacturer0000api.fda.gov
Innovation Labs, IncMahwah, NJ, United StatesContract manufacturer0000api.fda.gov
Jiangsu Ostup Medical Products Co. Ltd.Nanjing Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jiangsu Yizheng Carepro Medical Instruments Co., Ltd.Yizheng Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Newvalue Medical Products Co., Ltd.Taizhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Kosemed Ortopedi Sanayi Ve Ticaret Ithalat Ihracat Anonim SirketiSalihli Manisa, TurkeyManufacturer0000api.fda.gov
Lumaclean, LLCConcord, NC, United StatesSpecification developer0000api.fda.gov
Medicina LtdBlackrod Bolton, United KingdomComplaint file establishment, Specification developer0000api.fda.gov
Nanjing Anjian Medical Device Co.,ltd.Nanjing Jiangsu, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Ningbo MPF Manufacturing Co.,ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ostoform LtdMullingar Westmeath, IrelandExporter to the US, Repackager or relabeler, Specification developer0000api.fda.gov
Pharmapac (UK) LtdBidston Wirral, United KingdomContract manufacturer0000api.fda.gov
Remedy Medical ManufacturingMesa, AZ, United StatesContract manufacturer0000api.fda.gov
Saibainian Medical Technology (wuhan) Co., Ltd.Wuhan City Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
SEI Medical S.A. de C.V.Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Shandong Kangli Medical Equipment Technology Co., Ltd.Zaozhuang Shandong, ChinaManufacturer0000api.fda.gov
Shanghai Lions Industrial Co.,ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Shaoxing Haoshide Medical Products Co.,ltdShaoxing Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shanghai Jolly Industrial Co., Ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
T.G. Eakin, Ltd.COMBER, COUNTY DOWN Ards and North Down, United KingdomManufacturer0010api.fda.gov
Tongxiang Bao-Health Medical Instrument Co., Ltd.Tongxiang Zhejiang, ChinaManufacturer0000api.fda.gov
Tytex Denmark A/SIKAST Midtjylland, DenmarkSpecification developer0000api.fda.gov
Tytex Slovakia S.R.O.HUMENNE Presovsky, SlovakiaExporter to the US, Manufacturer0000api.fda.gov
Urocare Products, Inc.Pomona, CA, United StatesManufacturer0000api.fda.gov
Wuhan Sitaili Medical Apparatus Development Co.,ltdWuhan Hubei, ChinaManufacturer0000api.fda.gov
Yangzhou Zhilin Sports Items Co., LtdYangzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Yasco Enterprise Corp.Chiayi County Chiayi(County), TaiwanExporter to the US, Manufacturer0000api.fda.gov
ZHEJIANG Ailebao MEDICAL TECHNOLOGY CO., LTDWenzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Lidesen Medical Instrument Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhende Medical Co., Ltd.SHAOXING Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Longterm Medical Technology Co., LTDHuzhou City Zhejiang, ChinaManufacturer0000api.fda.gov

Updated March 6, 1991. 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.