BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EvoEndo Controller

    Reg #: 3015807001 · FEI: 3015807001 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    TAG3 ENGINEERING, LLC
    Registration Number
    3015807001
    FEI Number
    3015807001
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1161 Sawgrass Corporate Parkway
    City
    Sunrise
    State
    FL
    ZIP
    33323
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213606

    Owner / Operator

    Firm Name
    TAG3 ENGINEERING, LLC
    Operator Number
    10061288
    Address
    1161 Sawgrass Corporate Parkway
    City
    Sunrise
    State
    FL
    Postal Code
    33323
    Country
    US
    Correspondent
    DAMIAN H TOMLIN

    Products

    Device Name Product Code
    Gastroscope And Accessories, Flexible/Rigid FDS
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET

    Proprietary Names

    EvoEndo Controller EvoEndo Model LE Single-Use Gastroscope

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)