BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    OPCOM MEDICAL INC.

    Reg #: 3033010858 · FEI: 3033010858 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    OPCOM MEDICAL INC.
    Registration Number
    3033010858
    FEI Number
    3033010858
    Status
    Active
    Expiry Year
    2026
    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
    K242699

    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
    FullCircle26, Inc.
    Contact Name
    Shelley Mathews
    Address
    S42w34120 Hidden Valley Dr
    City
    Dousman
    State
    WI
    ZIP
    53118
    Country
    US
    Email
    [email protected]
    Phone
    224 2802034

    Products

    Device Name Product Code
    Stylet, Tracheal Tube BSR
    Laryngoscope, Non-Rigid CAL
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Laryngoscope, Rigid CCW
    Cystoscope And Accessories, Flexible/Rigid FAJ

    Proprietary Names

    laryngoscope U-Scope Cystoscope and accessories, flexible/rigid Cystoscope And Accessories, Flexible/Rigid

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device