Cofoe
One-piece Drainable IIeostomy Bag
25manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (7), Guangdong (7), Jiangsu (4). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| 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 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan | Guangdong | Repacker / relabeller | 62 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
Showing 12 of 25. All 25 manufacturers in China registered for Pouch, Colostomy
Record
| Listed by | Cofoe Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | EZQ |
| Device type | Pouch, Colostomy |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-12-09 |
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 |
|---|---|---|
| One-piece Drainable IIeostomy Bag(4326V) | In distribution | |
| One-piece Drainable IIeostomy Bag(4005C) | In distribution | |
| Two-piece Drainable IIeostomy Bag(08326V) | In distribution | |
| One-piece Drainable IIeostomy Bag (4010V) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SUR-FIT Natura | Convatec, Purchasing Department | 36 |
| Activelife | Convatec, Purchasing Department | 36 |
| Esteem+ | Convatec, Purchasing Department | 26 |
| Natura+ | Convatec, Purchasing Department | 19 |
| Esteem Synergy+ | Convatec, Purchasing Department | 12 |
| Flexi-Seal | Convatec, Purchasing Department | 6 |
| SUR-FIR Natura | Convatec, Purchasing Department | 1 |
| Eurotec Ease | Convatec, Purchasing Department | 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.