Zhangjiagang Shengang Medical Products Co., Ltd.
Registered establishment in Zhangjiagang, Jiangsu, China. 7 device types.
Zhangjiagang Shengang Medical Products Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Non-Surgical Gown, Respirator, Surgical and 5 other device types. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | ZHANGJIAGANG SHENGANG MEDICAL PRODUCTS CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016616327 |
| FEI number | 3016616327 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 张家港神港医疗用品有限公司 |
|---|---|
| Unified social credit code | 9132058277467958XE |
| Source | NMPA UDI database |
Location
| City | Zhangjiagang |
|---|---|
| Province | Jiangsu |
| Address | No.388 Yongjin Road, |
| Postal code | 215615 |
| Country | China |
What It Makes
| Device type | Class | Listed since | Chinese makers |
|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | 2020 | 439 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | Class 1 | 2020 | 47 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | Class 2 | 2022 | 51 |
| Non-Surgical Gown | Class 1 | 2020 | 318 |
| Patient Examination Glove | Class 1 | 2021 | 6 |
| Respirator, Surgical | Class 2 | 2020 | 118 |
| Tubes, Gastrointestinal (And Accessories) | Class 2 | 2022 | 25 |
Clearances
No clearance names Zhangjiagang Shengang Medical Products Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K082863 | 2009-01-09 | KNT | Traditional | Dynarex Corp. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2000 |
|---|---|
| Employees | 120-200 staff with 30+ technicians |
| Factory area | 13 mu (8000 sqm plant + 2000 sqm purification workshop) |
| Main products | Respiratory care supplies, Anesthesia supplies, Urology supplies, Surgery supplies, Enteral nutrition supplies |
| Certifications | 100000-grade purification workshop |
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.
The manufacturer named here can complete this record.