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9 catalogue numbers from 05225, listed by Coloplast A/S, Denmark, under Device, Incontinence, Urosheath Type, Non-Sterile. 13 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (8), Guangdong (3), Zhejiang (2). 3 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 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Clinisupplies (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 13 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Suzhou Texnet | Suzhou | Jiangsu | Contract manufacturer | 47 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Taicang Yigao Medical Technology Co., Ltd. | Taicang | Jiangsu | Manufacturer | 20 |
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Ningbo Greatcare Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 10 |
| Changshu Beyond Medical Device Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 9 |
| Shenzhen XFT Medical Limited | Shenzhen | Guangdong | Manufacturer | 8 |
Showing 12 of 13. All 13 manufacturers in China registered for Device, Incontinence, Urosheath Type, Non-Sterile
Record
| Listed by | Coloplast A/S, Denmark |
|---|---|
| FDA product code | NNX |
| Device type | Device, Incontinence, Urosheath Type, Non-Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5250 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-06 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Retail box of 35, shipper box of 6, shipper box of 100 |
| Sizes | Outer diameter 21 to 40 mm; lumen/inner diameter 25 to 40 mm; lumen/inner diameter 0.98 to 1.57 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 05225 | Lumen/Inner Diameter 25 mm | In distribution |
| 05240 | Outer Diameter 40 mm | In distribution |
| 05235 | Lumen/Inner Diameter 35 mm | In distribution |
| 05221 | Outer Diameter 21 mm | In distribution |
| 05240 | Lumen/Inner Diameter 1.57 in | In distribution |
| 05235 | Outer Diameter 35 mm | In distribution |
| 05230 | Outer Diameter 30 mm | In distribution |
| 05230 | Lumen/Inner Diameter 30 mm | In distribution |
| 05225 | Outer Diameter 25 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Clear Advantage Male Continence Sheath | C.R. Bard, Inc. | 40 |
| Spirit® Hydrocolloid Adhesive Sheath | C.R. Bard, Inc. | 30 |
| Aurora Hydrocolloide Adhesive Sheath | C.R. Bard, Inc. | 15 |
| Transfix Continence Sheath | C.R. Bard, Inc. | 15 |
| Freedom Clear | Coloplast A/S | 14 |
| UltraFlex™ Self-Adhering Male External Catheter | C.R. Bard, Inc. | 10 |
| Freedom Clear Advantage | Coloplast A/S | 10 |
| InView Extra | Hollister Incorporated | 10 |
| Wideband™ Self-Adhering Male External Catheter | C.R. Bard, Inc. | 10 |
| Clear Advantage Spirit Adhesive Sheath | C.R. Bard, Inc. | 10 |
| Pop-On™ Self-Adhering Male External Catheter | C.R. Bard, Inc. | 10 |
| InView Standard | Hollister Incorporated | 10 |
Showing 12 of 86. All products under Device, Incontinence, Urosheath Type, Non-Sterile
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.