OstomyGel
Ostomy accessory
7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (2), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Nanjing Anjian Medical Device Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 22 |
| Changzhou Major Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 31 |
| Shandong Kangli Medical Equipment Technology Co., Ltd. | Zaozhuang | Shandong | Manufacturer | 23 |
| Zhejiang Ailebao Medical Technology Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 11 |
| Tongxiang BAO-Health Medical Instrument Co., Ltd. | Tongxiang | Zhejiang | Manufacturer | 10 |
| Pinghu Sama Medical Packing Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 4 |
Record
| Listed by | DMC Importacao E Exportacao DE Equipamentos Ltda, Brazil |
|---|---|
| FDA product code | GDS |
| Device type | Bag, Stomal |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-04-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 290010003 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hollister | Hollister Incorporated | 9 |
| Halyard | O&M Halyard, Inc. | 3 |
| Stryker Fecal Management System | Sage Products LLC | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.