Ningbo Shun YE Medical Company, Ltd.
Registered establishment in Cixi Ningbo, Zhejiang, China. 8 device types, 2 clearances.
Ningbo Shun YE Medical Company, Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Stimulator, Nerve, Tube, Smoke Removal, Endoscopic and 6 other device types. Its earliest product listing with the FDA dates from 2011.
Registration
| Registered name | NINGBO SHUN YE MEDICAL COMPANY, LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009103001 |
| FEI number | 3009103001 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 宁波市舜业医疗器材有限公司 |
|---|---|
| Unified social credit code | 913302826913898195 |
| Source | NMPA UDI database |
Location
| City | Cixi Ningbo |
|---|---|
| Province | Zhejiang |
| Address | #5 Industrial Road, |
| Postal code | 315313 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Electrocautery, Gynecologic (And Accessories) | Class 2 | Bovie Electrode, Bovie Medical | 2011 | 6 |
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | Change-A-Tip Cauteries, Symmetry Surgical, Bovie Medical, High Temperature Cauteries, Low Temeperatire Cauteries, Micro Temp Fine and 3 more | 2011 | 65 |
| Light, Examination, Medical, Battery Powered | Class 1 | Penlights | 2011 | 53 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Eye Bubble | 2023 | 384 |
| Stimulator, Nerve | Class 2 | Nerve Locator | 2022 | 8 |
| System, Suction, Lipoplasty For Removal | Class 2 | 2025 | 2 | |
| Tube, Smoke Removal, Endoscopic | Class 1 | 2014 | 4 | |
| Unit, Cautery, Thermal, Battery-Powered | Class 2 | Bovie, Low Temperature Cauteries, Adjust Fine Tip Cauteries, Low-Temp Fine Cauteries | 2012 | 2 |
Clearances
2 clearances name Ningbo Shun YE Medical Company, Ltd. as applicant. 1 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 |
|---|---|---|---|---|
| K213786 | 2022-06-27 | GEI | Traditional | This company |
| K210256 | 2021-08-19 | FXX | Traditional | This company |
| K945757 | 1995-01-30 | GEI | Traditional | Aaron Medical Industries |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2009 |
|---|---|
| Main products | Medical diagnostic pens, Electrosurgical devices, Electrode instruments |
| Certifications | ISO13485, GMP, FDA QSR820 |
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.