BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Flexible Ureterorenoscope (US31E-12-EU, US31E-12-US)

    Reg #: 3035484431 · FEI: 3035484431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Innovex Medical (Malaysia) Sdn.Bhd
    Registration Number
    3035484431
    FEI Number
    3035484431
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.4, Jalan Laman Setia 7/5, Taman Laman Setia.
    City
    Gelang Patah Johor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K222737

    Owner / Operator

    Firm Name
    Shanghai AnQing Medical Instrument CO., Ltd.
    Operator Number
    10058112
    Address
    3rd Floor, No.2 Building,, 366 Huiqing Rd , East Zhangjiang High-Tech Park
    City
    Shanghai
    State
    CN-SH
    Postal Code
    201201
    Country
    CN

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

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

    Proprietary Names

    Flexible Ureterorenoscope (US31E-12-EU, US31E-12-US)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)