Data / Medical devices / China / Jiangsu Zhiyu Medical Instrument Co., Ltd
Jiangsu Zhiyu Medical Instrument Co., Ltd: FDA-registered device maker in West Taixing City Jiangsu, China, 1 510(k) clearance
Jiangsu Zhiyu Medical Instrument Co., Ltd is registered with the FDA (registration 3009392898) in West Taixing City Jiangsu, China. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 9, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009392898
- Address
- No.88, Nanyuan Road, Industrial Park, West Taixing City Jiangsu, China, 225400
- Owner or operator
- Jiangsu Zhiyu Medical Instrument Co., Ltd (10066140)
- Roles
- Manufacturer
- First device listed
- April 1, 2020
- Registered through
- 2026
- Brand names listed
- ACCESSORY, SURGICAL APPAREL, CATHETER, IRRIGATION, Needle, hypodermic, single lumen, Single-Use Sterile Microneedle Device, Syringe, piston
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Catheter, Irrigation | GBX | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Acupuncture, Single Use | MQX | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | 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 |
|---|---|---|---|---|---|---|
| May 9, 2023 | K212857 | Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use | FMF | Substantially Equivalent | Jiangsu Zhiyu Medical Instrument Co, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessory, Surgical Apparel
- All makers of Catheter, Irrigation
- All makers of Needle, Acupuncture, Single Use
- All makers of Syringe, Piston
- All makers of Needle, Hypodermic, Single Lumen
Updated May 9, 2023. 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.