Sensura Flex
37 catalogue numbers from 10105, 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
37catalogue 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 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Shipper box of 16, shipper box of 24, shipper box of 32, retail box of 5, shipper box of 8, shipper box of 20 |
| Sizes | Lumen/inner diameter 35 to 90 mm; total volume 655 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10105 | Lumen/Inner Diameter 50 mm | 10 | In distribution |
| 10915 | Descriptive Bag Size Maxi | 30 | In distribution |
| 10918 | Lumen/Inner Diameter 70 mm | 30 | In distribution |
| 11517 | Descriptive Bag Size Maxi | 20 | In distribution |
| 11612 | Lumen/Inner Diameter 50 mm | 20 | In distribution |
| 13644 | Total Volume 655 ml | In distribution | |
| 11302 | Base Plate Precut Start Hole Size – mm 15 | 5 | In distribution |
| 11314 | Base Plate Precut Start Hole Size – in 1 1/8 | 5 | In distribution |
| 11308 | Coupling Size Diameter – in 2 3/4 | 5 | In distribution |
| 10103 | Lumen/Inner Diameter 70 mm | 10 | In distribution |
| 10911 | Lumen/Inner Diameter 35 mm | 30 | In distribution |
| 10104 | Base Plate Type Flat | 10 | In distribution |
| 11315 | Base Plate Max Cut Size – in 1 5/16 | 5 | In distribution |
| 11512 | Descriptive Bag Size Maxi | 20 | In distribution |
| 13633 | Base Plate Precut Start Hole Size – mm 10 | In distribution | |
| 11591 | Descriptive Bag Size XXL | 20 | In distribution |
| 10108 | Base Plate Type Flat | 5 | In distribution |
| 10101 | Coupling Size Diameter – in 1 3/8 | 10 | In distribution |
| 11514 | Descriptive Bag Size Maxi | 20 | In distribution |
| 13634 | Base Plate Max Cut Size – mm 70 | In distribution | |
| 11312 | Lumen/Inner Diameter 35 mm | 5 | In distribution |
| 10106 | Base Plate Max Cut Size – mm 68 | 10 | In distribution |
| 10917 | Lumen/Inner Diameter 70 mm | 30 | In distribution |
| 10912 | Lumen/Inner Diameter 50 mm | 30 | In distribution |
| 11518 | Lumen/Inner Diameter 70 mm | 20 | In distribution |
| 11304 | Base Plate Precut Start Hole Size – mm 15 | 5 | In distribution |
| 11301 | Lumen/Inner Diameter 35 mm | 5 | In distribution |
| 11313 | Coupling Size Diameter – in 1 15/16 | 5 | In distribution |
| 11590 | Lumen/Inner Diameter 90 mm | 20 | In distribution |
| 11690 | Descriptive Bag Size XXL | 20 | In distribution |
| 11303 | Base Plate Type Convex Light | 5 | In distribution |
| 10102 | Coupling Size Diameter – in 1 15/16 | 10 | In distribution |
| 11305 | Base Plate Type Convex Light | 5 | In distribution |
| 10914 | Lumen/Inner Diameter 35 mm | 30 | In distribution |
| 11307 | Lumen/Inner Diameter 70 mm | 5 | In distribution |
| 11515 | Descriptive Bag Size Maxi | 20 | In distribution |
| 11306 | Base Plate Max Cut Size – in 1 11/16 | 5 | 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 |
| SenSura | Coloplast A/S | 53 |
| Karaya 5 | Hollister Incorporated | 38 |
| 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.