FDA Registration
Active
🇨🇳 China
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
Reg #: 3015540957
·
FEI: 3015540957
·
Expires 2026
Products
8
Proprietary Names
9
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
- Registration Number
- 3015540957
- FEI Number
- 3015540957
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.1 Xinxing Yilu Road, Emerging Industrial Cluster Area, Zonghan Subdistrict, Cixi City, Zhejiang
- City
- Cixi Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K240376
Owner / Operator
- Firm Name
- Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Operator Number
- 10060870
- Address
- No.1 Xinxing Yilu Road, Emerging Industrial Cluster Area, Zonghan Subdistrict, Cixi City, Zhejiang
- City
- Cixi
- State
- Zhejiang
- Postal Code
- 315301
- Country
- CN
- Correspondent
- Guofang Ma
US Agent
- Business Name
- MID-LINK INTERNATIONAL CO., LTD
- Contact Name
- Marco Mu
- Address
- 2219 Rimlang Drive, Suite 301
- City
- Bellingham
- State
- WA
- ZIP
- 98226
- Country
- US
- [email protected]
- Phone
- 702 2095185
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Low Energy Direct Current Thermal Ablation System | OAB | Class 2 | General, Plastic Surgery | No | 2025-09-25 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2023-10-24 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2021-12-27 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2021-12-27 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2021-12-27 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2022-08-03 |
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2022-08-03 |
| System, Ablation, Microwave And Accessories | NEY | Class 2 | General, Plastic Surgery | No | 2019-12-10 |
Proprietary Names
Electroporation System (N3000)
Gas Insufflator
Video Endoscopy System, 3D Video Endoscopy System
Energy Generator, Model: ES300, ES200, ES100
Electrosurgical mode of Ultrosonic Surgical & Eletrosurgical Generator, Model: SC300ES, SC200ES, SC100ES
Ultrasonic Surgical mode of Ultrasonic Surgical & Electrosurgical Generator, Model: SC300ES, SC200ES, SC100ES, SC200
Ultrasonic Scalpel System, Model: SC100E
Microwave Ablation System, model: M150E
Radio Frequency Ablation System, model: R150E
Establishment Types
Manufacture Medical Device