9line
Disposable SafeDwell Foley Catheter Monitor with Securement BX of 25
29manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (10), Hubei (4), Zhejiang (4). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen | Hubei | Contract manufacturer | 23 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Xiantao Rayxin Medical Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 18 |
| Qingdao Likangyuan Medical Device Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 14 |
| Hony Medical Co., Ltd. | Taishan | Guangdong | Contract manufacturer | 10 |
| Hangzhou Jimushi Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
Showing 12 of 29. All 29 manufacturers in China registered for Holder, Ureteral Catheter
Record
| Listed by | Rising Eagle Medical, United States |
|---|---|
| FDA product code | EYJ |
| Device type | Holder, Ureteral Catheter |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Complaint-file establishment |
| Premarket notification | Exempt |
| Record published | 2024-01-30 |
| Record revised | 2026-05-18 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Box of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R-8675309 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 13 |
| Centurion | Centurion Medical Products Corporation | 9 |
| McKesson | Mckesson Medical-Surgical Inc. | 8 |
| Dale Foley Catheter Holder | Dale Medical Products, Inc. | 6 |
| Catheter Stabilization Device | C.R. Bard, Inc. | 6 |
| Grip-Lok | Tidi Products, LLC | 6 |
| TruLock | HR Pharmaceuticals Inc. | 5 |
| Cardinal Health | Cardinal Health 200, LLC | 4 |
| Clik-FIX | Starboard Medical, Inc. | 4 |
| FlexGRIP | Bedal International NV | 3 |
| MC Johnson | Cardinal Health 200, LLC | 3 |
| MediChoice | Owens & Minor Distribution, Inc. | 3 |
Showing 12 of 34. All products under Holder, Ureteral Catheter
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.