Jiangsu Shenli Medical Production Co., Ltd.
Manufacturer and brand owner in Changzhou, Jiangsu, China. 6 device types, 9 products catalogued, 3 clearances.
Jiangsu Shenli Medical Production Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Arthroscope, Ear Irrigation Kit and 4 other device types. 9 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2007.
6device types registered with the FDA
9products catalogued under its own name
3510(k) clearances
87recalls
Registration
| Registered name | JIANGSU SHENLI MEDICAL PRODUCTION CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3003902757 |
| FEI number | 3003902757 |
| DUNS | 420611311 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 江苏神力医用制品有限公司 |
|---|---|
| Unified social credit code | 91320402251029051H |
| Source | NMPA UDI database |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | No 20, Changzheng Road |
| Postal code | 213111 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Arthroscope | Class 2 | IMC Irrigation SET | 2007 | 21 |
| Catheter, Continuous Irrigation | Class 1 | Catheter | 2017 | 6 |
| Ear Irrigation Kit | Class 1 | 2013 | 17 | |
| Ligator, Hemorrhoidal | Class 2 | 2018 | 12 | |
| Needle, Hypodermic, Single Lumen | Class 2 | Safety Blood Collection Set | 2017 | 71 |
| System, Irrigation, Urological | Class 2 | IMC Irrigation SET, Medline Y-Type TUR/Bladder Irrigation SET | 2007 | 8 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Tianzi | FMF | 5 |
| Syringe, Piston | FMF | 2 |
| DPS | FMF | 2 |
| Needle, Hypodermic, Single Lumen | FMI | 1 |
| Tianzi | FMI | 1 |
| BDS | FMI | 1 |
| Eclipse | FMF | 1 |
| North American Rescue | FMF | 1 |
| Eclipse | FMI | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K200557 | 2020-09-28 | PNR | Traditional | This company |
| K180259 | 2018-05-18 | FMI | Traditional | This company |
| K163093 | 2017-03-14 | FMI | Traditional | This company |
Recalls
40 of these are Class II. Class II means a temporary or reversible health consequence. 40 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 348800 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 4092250 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 749400 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 139100 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 619200 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 230800 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 12000 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 25200 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 454400 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 7000 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 7000 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 325500 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 0 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 62000 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 13574000 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 95200 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 525,700 syringes |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 777400 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 0 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 1248000 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 1700000 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 30800 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 400 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 1590000 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 12600 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 116160 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 124800 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 44800 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 1117800 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 50400 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 303800 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 98700 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 4800 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 483210 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 7000 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 0 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 37200 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 0 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 133600 |
| 2024-04-05 | Class II | No Marketing Application | Piston syringes sizes and configurations are out of the range of devices cleared under the firm’s 510(k). | 40800 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1987 |
|---|---|
| Main products | Sterile syringes, Infusion sets, Blood transfusion devices, IV needles, Intravenous needles |
| Export markets | International |
Nearby Manufacturers
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.
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