Cofoe
Ostomy Barrier Strips
7manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (1), Hunan (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 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Cofoe Medical Technology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 22 |
| Hubei Hendry Medical Appliance Co., Ltd. | Xiaogan | Hubei | Manufacturer | 12 |
| Tongxiang BAO-Health Medical Instrument Co., Ltd. | Tongxiang | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Cofoe Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | EZR |
| Device type | Cement, Stomal Appliance, Ostomy |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-12-09 |
| Record revised | 2025-03-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R2 | In distribution | |
| R4 | In distribution | |
| PU2 | In distribution | |
| A1 | In distribution | |
| PU1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| McKesson | Mckesson Medical-Surgical Inc. | 6 |
| Adapt | Hollister Incorporated | 2 |
| Bynex | Shaoxing Haoshide Medical Products Co., Ltd. | 2 |
| SecuriT | Hollister Incorporated | 2 |
| Karaya 5 | Hollister Incorporated | 1 |
| Tracho-Foam® Double-Sided Adhesive Foam Disc, Standard 2.25″ OD (Box of 30) | Urocare Products, Inc. | 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.