FDA Registration
Active
🇨🇳 China
Vathin® Single-use Flexible Cystoscope, CY-S1B01, CY-S1D01, CY-S1E01, CY-S1H01, CY-S1J01
Reg #: 3016045249
·
FEI: 3016045249
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
- Registration Number
- 3016045249
- FEI Number
- 3016045249
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1/F, Building 12, Innovation and Entrepreneurship Service Center, No.9 Chuanqi West road, Jiuhua Economic Development Zone,
- City
- Xiangtan Hunan
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K221580
Owner / Operator
- Firm Name
- Hunan Vathin Medical Instrument Co., Ltd.
- Operator Number
- 10062555
- Address
- Pittsfield, Massachusetts
- City
- Pittsfield
- State
- MA
- Postal Code
- 01201
- Country
- US
- Correspondent
- Lina Fei
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2022-12-17 |
Proprietary Names
Vathin® Single-use Flexible Cystoscope, CY-S1B01, CY-S1D01, CY-S1E01, CY-S1H01, CY-S1J01
Vathin® Single-use Flexible Cystoscope, CY-S1B01R, CY-S1D01R, CY-S1E01R, CY-S1H01R, CY-S1J01R
Vathin® Single-use Flexible Cystoscope, CY-S1B00R, CY-S1D00R, CY-S1E00R, CY-S1H00R, CY-S1J00R
Vathin® Single-use Flexible Cystoscope, CY-S1B00, CY-S1D00, CY-S1E00, CY-S1H00, CY-S1J00
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device