Data / Medical devices / Bag, Urinary, Ileostomy
Bag, Urinary, Ileostomy (EXH): 13 FDA-registered makers in 10 countries
13 establishments in 10 countries are registered with the FDA to make Bag, Urinary, Ileostomy (product code EXH, 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 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EXH
- Device class
- 1
- Regulation
- 876.5900
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| China | 3 |
| United Kingdom | 2 |
| Taiwan | 1 |
| Brazil | 1 |
| Dominican Republic | 1 |
| India | 1 |
| Mexico | 1 |
| Egypt | 1 |
| United States | 1 |
| Slovakia | 1 |
Makers of Bag, Urinary, Ileostomy
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 |
|---|---|---|---|---|---|---|---|---|
| Alger Technology Co., Ltd. | Taichung City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Casex, Ltda | Curitiba Parana, Brazil | 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 | |
| Hangzhou Rollmed Co.,ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Henan Maidingkang Medical Technology Co., Ltd. | Changyuan Henan, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heuer International (A division of GST Corporation Limited) | NOIDA Uttar Pradesh, India | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Plasticas Medicas, S.A. De C.V. | Ayala Morelos, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pharmaplast S.A.E. | ALEXANDRIA Al Iskandariyah, Egypt | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sarasota Medical Products | Sarasota, FL, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tongxiang Bao-Health Medical Instrument Co., Ltd. | Tongxiang Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unomedical S.R.O. | MICHALOVCE Kosicky, Slovakia | Manufacturer | 0 | 0 | 0 | 0 | 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.