BEUDAMED
    FDA Registration Active 🇨🇳 China

    Aptra™ Digital Endoscope System

    Reg #: 3020369549 · FEI: 3020369549 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NINGBO WISE OPTOMECH TECHNOLOGY CORPORATION
    Registration Number
    3020369549
    FEI Number
    3020369549
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2F, Building 12, Sankari Park, 688 Jinda Road, Yinzhou District
    City
    Ningbo Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K181977

    Owner / Operator

    Firm Name
    Ningbo Wise Optomech Technology Corporation
    Operator Number
    10058762
    Address
    No.86, Building 11, Innovation Park 128, Qiming Road, Yinzhou District,
    City
    Ningbo,
    State
    Zhejiang
    Postal Code
    315000
    Country
    CN
    Correspondent
    Jingjing Wei

    US Agent

    Business Name
    OTU Medical Inc.
    Contact Name
    Geping Liu
    Address
    1433 Bellemeade St
    City
    San Jose
    State
    CA
    ZIP
    95131
    Country
    US
    Email
    [email protected]
    Phone
    408 7977313

    Products

    Device Name Product Code
    Ureteroscope And Accessories, Flexible/Rigid FGB

    Proprietary Names

    Aptra™ Digital Endoscope System WiScope® Image System WiScope® Single-Use Digital Flexible Ureteroscope WiScope® Digital Endoscope System Aptra™ Image System Aptra™ Single-Use Digital Flexible Ureteroscope WiScope® Single-Use Digital Flexible UroScope

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)