Eakin
Eakin wound pouch 245mm x 160mm
49manufacturers in China registered for this device type
14catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (19), Jiangsu (9), Shanghai (7). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Henso Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Zhejiang TOP-Medical Medical Dressing Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 5 |
| 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 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
Showing 12 of 49. All 49 manufacturers in China registered for Bag, Drainage, With Adhesive, Ostomy
Record
| Listed by | T.G. Eakin, Ltd., United Kingdom |
|---|---|
| FDA product code | FON |
| Device type | Bag, Drainage, With Adhesive, Ostomy |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-05-16 |
| Record revised | 2026-01-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature 10 to 30 °C |
| Distribution end date | 2026-01-19 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 839267 | 10 | Withdrawn | |
| 839265 | 5 | Withdrawn | |
| 839264 | 5 | Withdrawn | |
| 839266 | 5 | Withdrawn | |
| 839268 | 5 | Withdrawn | |
| 839280 | 5 | Withdrawn | |
| 839251 | 10 | Withdrawn | |
| 839253 | 5 | Withdrawn | |
| 839260 | 10 | Withdrawn | |
| 839262 | 10 | Withdrawn | |
| 839250 | 10 | Withdrawn | |
| 839261 | 10 | Withdrawn | |
| 839263 | 5 | Withdrawn | |
| 839252 | 10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Esteem+ | Convatec, Purchasing Department | 92 |
| SUR-FIT Natura | Convatec, Purchasing Department | 60 |
| Natura | Convatec, Purchasing Department | 39 |
| Activelife | Convatec, Purchasing Department | 39 |
| AWI | Apex (Guangzhou) Tools & Orthopedics Company | 14 |
| AWI | Apex (Suzhou) Medical Products Company | 12 |
| Esteem Synergy | Convatec, Purchasing Department | 12 |
| Coloplast | Coloplast A/S | 8 |
| Carbou | Ningbo Kehu Medical Technology Co., Ltd. | 6 |
| ViveCare | Vive Health LLC | 6 |
| Perilav | Stiehl Tech | 5 |
| Osto System | Solomed S.A. DE C.V. | 4 |
Showing 12 of 24. All products under Bag, Drainage, With Adhesive, Ostomy
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.