FDA Registration
Active
🇨🇳 China
ZHEJIANG CURAWAY MEDICAL TECHNOLOGY CO., LTD
Reg #: 3017448139
·
FEI: 3017448139
·
Expires 2026
Products
7
Proprietary Names
11
Establishment Types
4
Classifications
7
Registration Details
- Registration Name
- ZHEJIANG CURAWAY MEDICAL TECHNOLOGY CO., LTD
- Registration Number
- 3017448139
- FEI Number
- 3017448139
- Status
- Active
- Expiry Year
- 2026
- 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 |
|---|---|---|---|---|---|
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2022-04-11 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2020-07-24 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2025-01-09 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2022-04-05 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2022-04-05 |
| Low Energy Direct Current Thermal Ablation System | OAB | Class 2 | General, Plastic Surgery | No | 2023-06-10 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2026-01-15 |
Proprietary Names
Automatic Core Biopsy Instrument
Pressure Bandage
Radiofrequency Generator, Cura RF Electrode
Breast Lesion Localization Wire, Soft Tissue Localization Wire
Disposable Needle Guider, Probe Spacer
Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe
Disposable Biopsy Needle
Noninvasive Skin Closure Device
Automatic Core Biopsy Instrument, Semi-Automatic Core Biopsy Instrument, Disposable Coaxial Biopsy Needle
Bone Marrow Biopsy Needle
Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Foreign Private Label Distributor