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
Bronchoscope (Flexible Or Rigid) EOQ

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