BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LUMENDI, LLC

    Reg #: 3013505983 · FEI: 3013505983 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    LUMENDI, LLC
    Registration Number
    3013505983
    FEI Number
    3013505983
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    253 Post Road W
    City
    Westport
    State
    CT
    ZIP
    06880
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210851

    Owner / Operator

    Firm Name
    Lumendi, LLC
    Operator Number
    10054295
    Address
    253 Post Road W
    City
    Westport
    State
    CT
    Postal Code
    06880
    Country
    US
    Correspondent
    Dennis J Daniels

    Products

    Device Name Product Code
    Colonoscope And Accessories, Flexible/Rigid FDF
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS

    Proprietary Names

    DiLumen EZ Glide DiLumen Ik, Endolumenal Interventional Kinfe DiLumen Is DiLumen C2 DiLumen Endolumenal Interventional Platform DiLumen Endolumenal Interventional Platform D-1000 DiLumen Endolumenal Interventional Platform D-1002 DiLumen Endolumenal Interventional Platform D-1001 DiLumen C1 EZ1 DiLumen Ig, Endolumenal Interventional Grasper

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility