Flexi-Seal
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25manufacturers in China registered for this device type
6catalogue 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 | Convatec, Purchasing Department |
|---|---|
| FDA product code | EZQ |
| Device type | Pouch, Colostomy |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Premarket notification | Exempt |
| Record published | 2022-09-09 |
| Record revised | 2022-11-15 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Inner carton of 10, shipper of 6, case of 6, case of 3, pack of 5, pack of 6 |
| Distribution end date | 2022-05-20 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 411102 | In distribution | ||
| 650078 | 10 | In distribution | |
| 411108 | In distribution | ||
| 418000 | In distribution | ||
| 422291 | In distribution | ||
| 411101 | 10 | Withdrawn |
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 |
| cofoe | Cofoe Medical Technology Co., Ltd. | 4 |
| 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.