BEUDAMED
    FDA Registration Active 🇺🇸 United States

    InSure One

    Reg #: 1226769 · FEI: 3003224146 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    ENTERIX INC.
    Registration Number
    1226769
    FEI Number
    3003224146
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    236 Fernwood Ave
    City
    EDISON
    State
    NJ
    ZIP
    08837
    Country
    US

    Regulatory Submissions

    510(k) Number
    K170548

    Owner / Operator

    Firm Name
    3T MEDICAL SYSTEMS, Inc
    Operator Number
    9043935
    Address
    236 Fernwood Ave
    City
    Edison
    State
    NJ
    Postal Code
    08837
    Country
    US
    Correspondent
    Erica Franco

    Products

    Device Name Product Code
    Reagent, Occult Blood KHE

    Proprietary Names

    InSure One

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device