BEUDAMED
    FDA Registration Active 🇨🇳 China

    HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.

    Reg #: 3016045249 · FEI: 3016045249 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    35
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
    Registration Number
    3016045249
    FEI Number
    3016045249
    Status
    Active
    Expiry Year
    2026
    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
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM

    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@ H-SteriScopeTM I Single-use flexible Video Bronchoscope, BCV1-01, BCV1-02, BCV1-C1, BCV1-C2, BCV1-H1, BCV1-H2 Vathin®Digital Video Monitor, DVM-A1, DVM-A2 Vathin@ H-SteriScopeTM I Single-use flexible Video Bronchoscope, BCV1-S1, BCV1-S2, BCV1-U1, BCV1-U2, BCV1-W1, BCV1-W2 Vathin@ H-SteriScopeTM I Single-use flexible Video Bronchoscope, BCV1-0M1, BCV1-0M2, BCV1-KS3-L Single-use Ureteral Access Sheath Single-use Flexible Ureteroscope, US-S2600, US-E2600, US-S2600R, US-E2600R Digital Video Monitor, DVM-B1 Single-use flexible Bronchoscope Digital Video Monitor Single-use sampler Vathin@ HSteriScopeTM I Single-use flexible Video Bronchoscope, BCV1- S1, BCV1-S2, BCV1-U1, BCV1-U2, BCV1-W1, BCV1-W2 Vathin®Digital Video Monitor, DVM-B1, DVM-B2 Vathin@ HSteriScopeTM I Single-use flexible Video Bronchoscope, BCV1- 01, BCV1-02, BCV1-C1, BCV1-C2, BCV1-H1, BCV1-H2 Vathin@ HSteriScopeTM I Single-use flexible Video Bronchoscope, BCV1- K1, BCV1-K2, BCV1- M1, BCV1-M2, BCV1- O1, BCV1-O2 Vathin@ HSteriScopeTM I Single-use flexible Video Bronchoscope, BCV1- 0M1, BCV1-0M2, BCV1-KS3-L Single-Use Ureteral Access Sheath Single-Use Flexible Rhinolaryngoscope Digital Video Processor Single-use Flexible Cystoscope Vathin® Video Bronchoscope System Single-use Flexible Ureteroscope Vathin® Single-use Flexible Ureteroscope, US-S170, US-E170, US-S180, US-E180 Vathin® Single-use Flexible Ureteroscope, US-S170R, US-E170R Trolley with pylon , MET-A2 Trolley,MET-A1,MC-A1 Pylon , ST-A1,MP-A1,MP-A2,MP-A3 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-S1B00, CY-S1D00, CY-S1E00, CY-S1H00, CY-S1J00 Vathin® Single-use Flexible Cystoscope, CY-S1B00R, CY-S1D00R, CY-S1E00R, CY-S1H00R, CY-S1J00R Vathin® Video Rhinolaryngoscope System Digital Video Processor (SYS-5100) Single-use Flexible Bronchoscope

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device