FDA Registration
Active
🇨🇳 China
Radiofrequency Generator, Cura RF Electrode
Reg #: 3017448139
·
FEI: 3017448139
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- ZHEJIANG CURAWAY MEDICAL TECHNOLOGY CO., LTD
- Registration Number
- 3017448139
- FEI Number
- 3017448139
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 106, Building 1, No.600, 21st Avenue, Baiyang Sub-district, Qiantang New District
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K240758
Owner / Operator
- Firm Name
- Zhejiang CuraWay Medical Technology Co., Ltd.
- Operator Number
- 10076584
- Address
- Room 106, Building 1, No.600, 21st Avenue, Baiyang Sub-district, Qiantang New District
- City
- Hangzhou City
- State
- Zhejiang
- Postal Code
- 310018
- Country
- CN
- Correspondent
- Yao Zhang
US Agent
- Business Name
- Performance International Inc.
- Contact Name
- Dennis Xu
- Address
- 4004 Pepperton Dr.
- City
- Raleigh
- State
- NC
- ZIP
- 27606
- Country
- US
- [email protected]
- Phone
- 919 8590478
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2025-01-09 |
Proprietary Names
Radiofrequency Generator, Cura RF Electrode
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Foreign Private Label Distributor