SenSura Mio Baby
2 catalogue numbers from 18700, 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
2catalogue 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 | 2025-02-06 (version 2) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Do not use if package is damaged and consult IFU. |
| Packaging | Retail box of 10, shipper box of 16, shipper box of 32, retail box of 5 |
| Sizes | Lumen/inner diameter 40 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 18700 | Coupling Size Diameter – in 1 9/16 | In distribution |
| 18705 | Base Plate Precut Start Hole Size – mm 0 | 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 |
| Sensura Flex | Coloplast A/S | 37 |
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.