BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Cystoscope and accessories, flexible/rigid

    Reg #: 3033010858 · FEI: 3033010858 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OPCOM MEDICAL INC.
    Registration Number
    3033010858
    FEI Number
    3033010858
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12F, No.6, JianKang Rd., Zhonghe Dist., New Taipei City 23586, Taiwan(R.O.C.)
    City
    New Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K171500

    Owner / Operator

    Firm Name
    OPCOM Medical Inc.
    Operator Number
    10090696
    Address
    12F, No.6, JianKang Rd., Zhonghe Dist., New Taipei City 23586, Taiwan(R.O.C.)
    City
    New Taipei City
    State
    TW-NWT
    Postal Code
    23586
    Country
    TW
    Correspondent
    Ching Lin Huang

    US Agent

    Business Name
    UroViu Corporation
    Contact Name
    Yuan Xu
    Address
    4546 El Camino Real, Suite 214 Los Altos, CA
    City
    Los Altos
    State
    CA
    ZIP
    94022
    Country
    US
    Email
    [email protected]
    Phone
    510 2989399

    Products

    Device Name Product Code
    Cystoscope And Accessories, Flexible/Rigid FAJ

    Proprietary Names

    Cystoscope and accessories, flexible/rigid

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)