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
| Country | Makers |
|---|---|
| China | 29 |
| United States | 8 |
| United Kingdom | 7 |
| Taiwan | 2 |
| Brazil | 1 |
| Dominican Republic | 1 |
| Pakistan | 1 |
| Lithuania | 1 |
| Turkey | 1 |
| Ireland | 1 |
| Mexico | 1 |
| Denmark | 1 |
| Slovakia | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Anji Spenq Industrial Co., Ltd. | Huzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Austin Medical Products, Inc. | Portland, ME, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Casex, Ltda | Curitiba Parana, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clinical Polymer Technologies Ltd | Coalville Leicestershire, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cofoe Medical Technology Co.,ltd | Changsha Hunan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Concarey Medical Technology Co., Ltd | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Convatec Dominican Republic, Inc. | Haina San Cristobal, Dominican Republic | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Convatec Limited | Deeside Flintshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ConvaTec Limited, GDC Building | Deeside Flintshire, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Euromed, Inc. | Orangeburg, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fortune Medical Instrument Corp. | Taoyuan City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gbuk Group Limited | Selby North Yorkshire, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haiyan Kangyuan Medical Instrument Co.,ltd. | JiaXing Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Rollmed Co.,ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Henso Medical (hangzhou) Co.,ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hollister Incorporated | Libertyville, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hollister Incorporated | Stuarts Draft, VA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Hendry Medical Appliance Co., Ltd | Xiaogan City Hubei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huida Biopharmaceuticals (suzhou) Ltd | SUZHOU Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huzhou Junda Industry Co., Ltd. | Anji Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou City Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heaven Healthcare Co., Ltd. | Shaoxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hollister Lietuva UAB | Kaunas district, Lithuania | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovation Labs, Inc | Mahwah, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Ostup Medical Products Co. Ltd. | Nanjing Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Yizheng Carepro Medical Instruments Co., Ltd. | Yizheng Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Newvalue Medical Products Co., Ltd. | Taizhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kosemed Ortopedi Sanayi Ve Ticaret Ithalat Ihracat Anonim Sirketi | Salihli Manisa, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lumaclean, LLC | Concord, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medicina Ltd | Blackrod Bolton, United Kingdom | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanjing Anjian Medical Device Co.,ltd. | Nanjing Jiangsu, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo MPF Manufacturing Co.,ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ostoform Ltd | Mullingar Westmeath, Ireland | Exporter to the US, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pharmapac (UK) Ltd | Bidston Wirral, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remedy Medical Manufacturing | Mesa, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Saibainian Medical Technology (wuhan) Co., Ltd. | Wuhan City Hubei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SEI Medical S.A. de C.V. | Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Kangli Medical Equipment Technology Co., Ltd. | Zaozhuang Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Lions Industrial Co.,ltd. | Shanghai, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shaoxing Haoshide Medical Products Co.,ltd | Shaoxing Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| T.G. Eakin, Ltd. | COMBER, COUNTY DOWN Ards and North Down, United Kingdom | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Tongxiang Bao-Health Medical Instrument Co., Ltd. | Tongxiang Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tytex Denmark A/S | IKAST Midtjylland, Denmark | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tytex Slovakia S.R.O. | HUMENNE Presovsky, Slovakia | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Urocare Products, Inc. | Pomona, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuhan Sitaili Medical Apparatus Development Co.,ltd | Wuhan Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Zhilin Sports Items Co., Ltd | Yangzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yasco Enterprise Corp. | Chiayi County Chiayi(County), Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZHEJIANG Ailebao MEDICAL TECHNOLOGY CO., LTD | Wenzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Lidesen Medical Instrument Co., Ltd | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhende Medical Co., Ltd. | SHAOXING Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Longterm Medical Technology Co., LTD | Huzhou City Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.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.