Areza Medical
2 catalogue numbers from COPOV10, listed by Advanced Medical Associates, LLC, United States, under Bag, Drainage, With Adhesive, Ostomy. 49 manufacturers in China are registered for this product code.
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 | Advanced Medical Associates, LLC, United States |
|---|---|
| FDA product code | FON |
| Device type | Bag, Drainage, With Adhesive, Ostomy |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Establishment | Repacker / relabeller, Complaint-file establishment |
| Premarket notification | Exempt |
| Record published | 2024-10-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store in a cool, dry place. Avoid excessive heat |
| Packaging | Inner case of 10, case of 30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| COPOV10 | 10 | In distribution | |
| COPOVV10 | 10 | In distribution |
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 |
| Eakin | T.G. Eakin, Ltd. | 14 |
| 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 |
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.