SenSura
53 catalogue numbers from 15697, listed by Coloplast A/S, Denmark, under Collector, Ostomy. 18 manufacturers in China are registered for this product code.
18manufacturers in China registered for this device type
53catalogue numbers in this listing
11510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (7), Zhejiang (4), Shanghai (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Nanjing Anjian Medical Device Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 22 |
| Shaoxing Haoshide Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Jiangsu WLD Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 50 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Aimi Health Technology (Guangdong) Co., Ltd. | Dongguan | Guangdong | Manufacturer | 21 |
| Wenzhou Zuoyou Medical Technoloyg Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 21 |
Showing 12 of 18. All 18 manufacturers in China registered for Collector, Ostomy
Record
| Listed by | Coloplast A/S, Denmark |
|---|---|
| FDA product code | EXB |
| Device type | Collector, Ostomy |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-02 |
| Record revised | 2024-07-23 (version 2) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Do not use if package is damaged and consult IFU. |
| Packaging | Shipper box of 16, shipper box of 10, retail box of 5, shipper box of 12, shipper box of 20, shipper box of 8 |
| Sizes | Lumen/inner diameter 40 to 60 mm; total volume 400 to 655 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 15697 | Base Plate Type Convex Light | 10 | In distribution |
| 19030 | Base Plate Precut Start Hole Size – mm 10 | In distribution | |
| 15534 | Base Plate Precut Start Hole Size – mm 35 | 20 | In distribution |
| 11814 | Base Plate Type Convex Light | 10 | In distribution |
| 11817 | Base Plate Type Convex Light | 10 | In distribution |
| 15524 | Descriptive Bag Size Maxi | 20 | In distribution |
| 13612 | Total Volume 400 ml | In distribution | |
| 15533 | Descriptive Bag Size Maxi | 20 | In distribution |
| 15623 | Base Plate Precut Start Hole Size – in 1 | 10 | In distribution |
| 11819 | Base Plate Precut Start Hole Size – in 9/16 | 10 | In distribution |
| 19004 | Base Plate Type Flat | 30 | In distribution |
| 11816 | Descriptive Bag Size Maxi | 10 | In distribution |
| 19010 | Base Plate Precut Start Hole Size – in 3/8 | In distribution | |
| 19001 | Base Plate Type Flat | In distribution | |
| 19051 | Coupling Size Diameter – in 1 15/16 | 10 | In distribution |
| 15991 | Base Plate Type Flat | 10 | In distribution |
| 13630 | Base Plate Type Flat | In distribution | |
| 15981 | Base Plate Type Flat | 10 | In distribution |
| 11808 | Descriptive Bag Size Maxi | 10 | In distribution |
| 15532 | Base Plate Type Flat | 20 | In distribution |
| 15624 | Base Plate Type Convex Light | 10 | In distribution |
| 15484 | Base Plate Type Flat | 30 | In distribution |
| 19042 | Lumen/Inner Diameter 60 mm | 10 | In distribution |
| 19052 | Descriptive Bag Size Magnum | 10 | In distribution |
| 11818 | Descriptive Bag Size Maxi | 10 | In distribution |
| 15992 | Base Plate Precut Start Hole Size – mm 30 | 10 | In distribution |
| 15480 | Base Plate Type Flat | 30 | In distribution |
| 19020 | Base Plate Max Cut Size – in 3 1/16 | In distribution | |
| 11805 | Base Plate Type Flat | 10 | In distribution |
| 15606 | Base Plate Max Cut Size – in 1 11/16 | 10 | In distribution |
| 11806 | Base Plate Type Flat | 10 | In distribution |
| 11807 | Descriptive Bag Size Maxi | 10 | In distribution |
| 15821 | Base Plate Type Flat | 20 | In distribution |
| 15698 | Base Plate Precut Start Hole Size – mm 25 | 10 | In distribution |
| 15608 | Base Plate Max Cut Size – mm 43 | 10 | In distribution |
| 11809 | Base Plate Type Flat | 10 | In distribution |
| 19050 | Lumen/Inner Diameter 40 mm | 10 | In distribution |
| 15522 | Base Plate Type Flat | 20 | In distribution |
| 15695 | Base Plate Type Convex Light | 10 | In distribution |
| 19041 | Descriptive Bag Size Magnum | 10 | In distribution |
| 15696 | Base Plate Type Convex Light | 10 | In distribution |
| 11804 | Base Plate Type Flat | 10 | In distribution |
| 15994 | Base Plate Precut Start Hole Size – mm 38 | 10 | In distribution |
| 11803 | Base Plate Precut Start Hole Size – in 3/8 | 10 | In distribution |
| 15633 | Base Plate Precut Start Hole Size – mm 25 | 10 | In distribution |
| 15521 | Base Plate Precut Start Hole Size – in 3/8 | 20 | In distribution |
| 15993 | Descriptive Bag Size Maxi | 10 | In distribution |
| 19040 | Descriptive Bag Size Magnum | 10 | In distribution |
| 19011 | Base Plate Type Flat | In distribution | |
| 19021 | Base Plate Type Flat | In distribution | |
| 15531 | Base Plate Precut Start Hole Size – in 3/8 | 20 | In distribution |
| 15523 | Base Plate Precut Start Hole Size – mm 30 | 20 | In distribution |
| 15634 | Base Plate Precut Start Hole Size – in 1 1/8 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Assura | Coloplast A/S | 252 |
| New Image | Hollister Incorporated | 236 |
| SenSura Mio | Coloplast A/S | 200 |
| Premier | Hollister Incorporated | 182 |
| SenSura Mio Convex | Coloplast A/S | 162 |
| SenSura Mio Convex brand logo | Coloplast A/S | 82 |
| SenSura Click | Coloplast A/S | 69 |
| Securi-T | Hollister Incorporated | 59 |
| SenSura Mio Convex Flip | Coloplast A/S | 58 |
| Karaya 5 | Hollister Incorporated | 38 |
| Sensura Flex | Coloplast A/S | 37 |
| Brava | Coloplast A/S | 31 |
Showing 12 of 31. All products under Collector, Ostomy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K881636 | 1988-07-13 |
| K861070 | 1986-06-16 |
| K844685 | 1985-01-08 |
| K833567 | 1984-05-02 |
| K840267 | 1984-04-02 |
| K840265 | 1984-04-02 |
| K840269 | 1984-04-02 |
| K833571 | 1984-01-30 |
| K833565 | 1984-01-30 |
| K833569 | 1983-12-27 |
| K833566 | 1983-12-27 |
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.