Emsrun
Catalogue number CR-B1, listed by Wuxi Emsrun Technology Co., Ltd., under Catheter, Infusion. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (3), Shandong (2), Zhejiang (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
| Nanjing J SUN Healthcare Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 56 |
| Ningbo Risenmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 42 |
| Zhejiang Anji Huabu Industrial Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 32 |
| PRO-MED (Wuxi)IMP.& Exp.co., Ltd. | Wuxi | Jiangsu | Exporter | 24 |
Record
| Listed by | Wuxi Emsrun Technology Co., Ltd. |
|---|---|
| FDA product code | JCY |
| Device type | Catheter, Infusion |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Premarket notification | Exempt |
| Record published | 2022-12-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CR-B1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Infusion Catheterinfusion Catheter | Medical Components Inc | 5 |
| N/AN/A | Medical Components Inc | 4 |
| Triple Lumen Infusion Catheterstriple Lumen Infusion Catheters | Medical Components Inc | 1 |
| Halyard | O&M Halyard, Inc. | 1 |
| Triple Lumen Infusion Catheters | Medical Components Inc | 1 |
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.