Data / Medical devices / China / Zhangjiagang Shengang Medical Products Co.,ltd
Zhangjiagang Shengang Medical Products Co.,ltd: FDA-registered device maker in Zhangjiagang Jiangsu, China, 1 510(k) clearance
Zhangjiagang Shengang Medical Products Co.,ltd is registered with the FDA (registration 3016616327) in Zhangjiagang Jiangsu, China. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 9, 2009. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3016616327
- Address
- No.388 Yongjin Road, Tangqiao Town, Zhangjiagang Jiangsu, China, 215615
- Owner or operator
- Zhangjiagang Shengang Medical Products Co.,Ltd (10063070)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- March 16, 2020
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Patient Examination Glove | FMC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 9, 2009 | K082863 | DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML) | KNT | Substantially Equivalent | Dynarex Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Non-Surgical Gown
- All makers of Respirator, Surgical
- All makers of Patient Examination Glove
- All makers of Accessory, Surgical Apparel
- All makers of Bag, Urine Collection, Leg, For External Use, Non-Sterile
Updated January 9, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.