FDA Registration
Active
🇨🇳 China
Vathin@ H-SteriScopeTM I Single-use flexible Video Bronchoscope, BCV1-K1, BCV1-K2, BCV1-M1, BCV1-M2, BCV1-O1, BCV1-O2
Reg #: 3016045249
·
FEI: 3016045249
·
Expires 2025
Products
1
Proprietary Names
6
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
- K213635
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 |
|---|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2022-03-09 |
Proprietary Names
Vathin@ H-SteriScopeTM I Single-use flexible Video Bronchoscope, BCV1-K1, BCV1-K2, BCV1-M1, BCV1-M2, BCV1-O1, BCV1-O2
Vathin@ Digital Video Processor, DVP-A1
Vathin®Digital Video Monitor, DVM-A1, DVM-A2
Vathin@ H-SteriScopeTM I Single-use flexible Video Bronchoscope, BCV1-01, BCV1-02, BCV1-C1, BCV1-C2, BCV1-H1, BCV1-H2
Vathin@ H-SteriScopeTM I Single-use flexible Video Bronchoscope, BCV1-0M1, BCV1-0M2, BCV1-KS3-L
Vathin@ H-SteriScopeTM I Single-use flexible Video Bronchoscope, BCV1-S1, BCV1-S2, BCV1-U1, BCV1-U2, BCV1-W1, BCV1-W2
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device