Data / Medical devices / Bag, Stomal
Bag, Stomal (GDS): 13 FDA-registered makers in 4 countries
13 establishments in 4 countries are registered with the FDA to make Bag, Stomal (product code GDS, 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 2 510(k) clearances under this code, the latest on September 29, 1988, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GDS
- Device class
- 1
- Regulation
- 876.5900
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| China | 7 |
| United States | 4 |
| Brazil | 1 |
| Cambodia | 1 |
Makers of Bag, Stomal
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 |
|---|---|---|---|---|---|---|---|---|
| Averto Medical | Redwood City, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Major Medical Products Co., Ltd. | CHANGZHOU Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DMC Importacao E Exportacao De Equipamentos Ltda | Sao Carlos Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guardmed Healthcare KH Co., Ltd. | Bati District Takeo, Cambodia | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Rollmed 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 | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanjing Anjian Medical Device Co.,ltd. | Nanjing Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pinghu Sama Medical Packing Co., Ltd. | Pinghu Zhejiang, China | 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 | |
| Shandong Kangli Medical Equipment Technology Co., Ltd. | Zaozhuang Shandong, China | 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 | |
| ZHEJIANG Ailebao MEDICAL TECHNOLOGY CO., LTD | Wenzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 29, 1988. 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.