CeraPlus
2-Piece Ostomy Drainable Pouch and Soft Convex Skin Barrier Tape Kits
3manufacturers in China registered for this device type
11catalogue 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 | Hollister Incorporated, United States |
|---|---|
| FDA product code | PQE |
| Device type | Ostomy Care Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-03-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 24 |
| Sizes | Lumen/inner diameter 25 to 70 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 89001C | Lumen/Inner Diameter 64 mm | 5 | In distribution |
| 19003C | Lumen/Inner Diameter 38 mm | 5 | In distribution |
| 89003C | Lumen/Inner Diameter 55 mm | 5 | In distribution |
| 19202C | Lumen/Inner Diameter 25 mm | 5 | In distribution |
| 19004C | Lumen/Inner Diameter 51 mm | 5 | In distribution |
| 89004C | Lumen/Inner Diameter 55 mm | 5 | In distribution |
| 19002C | Lumen/Inner Diameter 44 mm | 5 | In distribution |
| 19204C | Lumen/Inner Diameter 70 mm | 5 | In distribution |
| 89005C | Lumen/Inner Diameter 55 mm | 5 | In distribution |
| 89002C | Lumen/Inner Diameter 64 mm | 5 | In distribution |
| 19203C | Lumen/Inner Diameter 57 mm | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| New Image | Hollister Incorporated | 44 |
| Natura | Convatec, Purchasing Department | 12 |
| Bynex | Shaoxing Haoshide Medical Products Co., Ltd. | 10 |
| 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.