Stomahesive
Stomahesive® Skin Barrier - 8" X 8" Wafers
33manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (14), Jiangsu (9), Shanghai (3). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Nanjing Anjian Medical Device Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 22 |
| Haiyan Kangyuan Medical Instrument Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 17 |
| Zhende Medical Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 14 |
| Zhejiang Ailebao Medical Technology Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 11 |
| Jiangsu Yizheng Carepro Medical Instruments Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 8 |
| Shaoxing Haoshide Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Huida Biopharmaceuticals (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
Showing 12 of 33. All 33 manufacturers in China registered for Protector, Ostomy
Record
| Listed by | Convatec, Purchasing Department |
|---|---|
| FDA product code | EXE |
| Device type | Protector, Ostomy |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Premarket notification | Exempt |
| Record published | 2022-10-14 |
| Record revised | 2023-01-09 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 20, pack of 35, pack of 10, pack of 48, case of 10 |
| Distribution end date | 2023-02-26 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 183910 | In distribution | ||
| 021715 | 3 | In distribution | |
| 025510 | In distribution | ||
| 025542 | 15 | In distribution | |
| 021712 | 5 | In distribution | |
| 021901 | 5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AMPatch Stoma Cover | Austin Medical Products, Inc. | 200 |
| SUR-FIT Natura | Convatec, Purchasing Department | 73 |
| Esteem Synergy | Convatec, Purchasing Department | 25 |
| Natura | Convatec, Purchasing Department | 23 |
| Adapt | Hollister Incorporated | 19 |
| Eakin | T.G. Eakin, Ltd. | 11 |
| Esenta | Convatec, Purchasing Department | 10 |
| CeraPlus | Hollister Incorporated | 9 |
| Adapt CeraRing | Hollister Incorporated | 8 |
| ViveCare | Vive Health LLC | 5 |
| Vive | Vive Health LLC | 4 |
| Hollister | Hollister Incorporated | 4 |
Showing 12 of 25. All products under Protector, Ostomy
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.