Securi-T
1-Pc Ostomy System, Convex
27manufacturers in China registered for this device type
11catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (9), Jiangsu (6), Shanghai (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 |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Ningbo Great Mountain Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 12 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| Jiangsu WLD Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 50 |
| Ningbo Risenmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 42 |
| Rusun Medical Co., Ltd. | Yichun | Jiangxi | Manufacturer | 37 |
Showing 12 of 27. All 27 manufacturers in China registered for Bag, Urine Collecting, Ureterostomy
Record
| Listed by | Hollister Incorporated, United States |
|---|---|
| FDA product code | EXG |
| Device type | Bag, Urine Collecting, Ureterostomy |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-01 |
| Record revised | 2025-06-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Lumen/inner diameter 19 to 57 mm |
| Distribution end date | 2025-05-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 7502214 | Lumen/Inner Diameter 57 mm | 10 | Withdrawn |
| 7501134 | Lumen/Inner Diameter 45 mm | 10 | Withdrawn |
| 7610198 | Lumen/Inner Diameter 19 mm | 10 | Withdrawn |
| 7502134 | Lumen/Inner Diameter 45 mm | 10 | Withdrawn |
| 7610258 | Lumen/Inner Diameter 25 mm | 10 | Withdrawn |
| 7610228 | Lumen/Inner Diameter 22 mm | 10 | Withdrawn |
| 7610328 | Lumen/Inner Diameter 32 mm | 10 | Withdrawn |
| 7610298 | Lumen/Inner Diameter 29 mm | 10 | Withdrawn |
| 7503214 | Lumen/Inner Diameter 57 mm | 10 | Withdrawn |
| 7501214 | Lumen/Inner Diameter 57 mm | 10 | Withdrawn |
| 7503134 | Lumen/Inner Diameter 45 mm | 10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premier | Hollister Incorporated | 87 |
| Safe N Simple | Safe N Simple LLC | 30 |
| New Image | Hollister Incorporated | 18 |
| Emsrun | Wuxi Emsrun Technology Co., Ltd. | 6 |
| Karaya 5 | Hollister Incorporated | 5 |
| Lightning X Products,Inc | Wuxi Emsrun Technology Co., Ltd. | 5 |
| MDK-Medical | Henan Maidingkang Medical Technology Co., Ltd. | 3 |
| Bag, Urine Collecting, Ureterostomy | Henan Maidingkang Medical Technology Co., Ltd. | 2 |
| Pouchkins | Hollister Incorporated | 2 |
| McKesson | Mckesson Medical-Surgical Inc. | 1 |
| SecuriT | Hollister Incorporated | 1 |
| Esteem+ | Convatec, Purchasing Department | 1 |
Showing 12 of 13. All products under Bag, Urine Collecting, Ureterostomy
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.