BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ENvue Medical (USA) Inc.

    Reg #: 3017081712 · FEI: 3017081712 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ENvue Medical (USA) Inc.
    Registration Number
    3017081712
    FEI Number
    3017081712
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    762 W. Algonquin Road
    City
    Arlington Heights
    State
    IL
    ZIP
    60005
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191387

    Owner / Operator

    Firm Name
    ENvizion Medical Ltd
    Operator Number
    10048397
    Address
    26 HaBarzel
    City
    Tel Aviv
    State
    IL-TA
    Postal Code
    6971036
    Country
    IL

    Products

    Device Name Product Code
    Tubes, Gastrointestinal (And Accessories) KNT
    Gastrointestinal Tubes With Enteral Specific Connectors PIF

    Proprietary Names

    ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube ENvue ENvizion Medical Enteral Feeding Tube

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility