Bynex
Two-piece ostomy bag Convex Wafer 5 pieces/box 30 boxes/carton
3manufacturers in China registered for this device type
10catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (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 |
|---|---|---|---|---|
| Zhende Medical Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 14 |
| Shaoxing Haoshide Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Suzhou Kangyouwei Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Shaoxing Haoshide Medical Products Co., Ltd., China |
|---|---|
| FDA product code | PQE |
| Device type | Ostomy Care Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-08-03 |
| Record revised | 2024-02-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20, case of 30, case of 15, case of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2251V | In distribution | |
| 2151V | In distribution | |
| 12071V | In distribution | |
| 11071V | In distribution | |
| 21143 | In distribution | |
| 2252 | In distribution | |
| 22055 | In distribution | |
| 22143 | In distribution | |
| 12141V | In distribution | |
| 21055 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| New Image | Hollister Incorporated | 44 |
| Natura | Convatec, Purchasing Department | 12 |
| CeraPlus | Hollister Incorporated | 11 |
| Hollister | Hollister Incorporated | 6 |
| Premier | Hollister Incorporated | 5 |
| ZD | Zhende Medical Co., Ltd. | 2 |
| Brava | Coloplast A/S | 1 |
| Bynex | Zhende Medical Co., Ltd. | 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.