Data / Medical devices / China / Ningbo Shun Ye Medical Company, Ltd.
Ningbo Shun Ye Medical Company, Ltd.: FDA-registered device maker in Cixi Ningbo Zhejiang, China, 1 510(k) clearance
Ningbo Shun Ye Medical Company, Ltd. is registered with the FDA (registration 3009103001) in Cixi Ningbo Zhejiang, China. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 30, 1995. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3009103001
- Address
- #5 Industrial Road, ZhangQi Industry Zone, Cixi Ningbo Zhejiang, China, 315313
- Owner or operator
- Ningbo Shun Ye Medical Company, Ltd. (10037350)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 7, 2011
- Registered through
- 2027
- Brand names listed
- Adjust Fine Tip Cauteries, Bovie, Bovie Electrode, Bovie Medical, Change-A-Tip Cauteries, Change-A-Tip cauteries, Electrosurgical Electrodes, Eye Bubble and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocautery, Gynecologic (And Accessories) | HGI | 2 | Contract manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Light, Examination, Medical, Battery Powered | KYT | 1 | Manufacturer | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Nerve | ETN | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Suction, Lipoplasty For Removal | QPB | 2 | Contract manufacturer | accessdata.fda.gov |
| Tube, Smoke Removal, Endoscopic | FCZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Unit, Cautery, Thermal, Battery-Powered | HQP | 2 | Contract 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 30, 1995 | K945757 | HIGH TEMPERATURE CAUTERY FINE ADJUSTABLE | GEI | Substantially Equivalent | Aaron Medical Industries | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of System, Suction, Lipoplasty For Removal
- All makers of Tube, Smoke Removal, Endoscopic
- All makers of Unit, Cautery, Thermal, Battery-Powered
- All makers of Light, Examination, Medical, Battery Powered
- All makers of Stimulator, Nerve
Updated January 30, 1995. 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.